The antiviral molnupiravir, according to Merck-MSD, halves the risk of hospitalization and death. Burioni: The trial was stopped due to overwhelming effectiveness. The pharmaceutical company will ask for authorization for emergency use
Impressive results. This is how immunologist and White House consultant Anthony Fauci comments on the data of the anti Covid pill developed by the pharmaceutical company Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics. Results that have aroused great enthusiasm around the world because the drug molnupiravir would be able to reduce the risk of hospitalization and death from Covid by 50% in unvaccinated Sars-CoV2 positive subjects treated within five days of starting symptoms. The pharmaceutical company said in a statement that it will ask the US FDA and then other regulatory bodies around the world for authorization. for emergency use of the pill antiviral molnupiravir for the treatment of Covid after an advanced clinical trial showed that the drug has in fact halved the risk of hospitalization and death.
The pharmaceutical company announced it had stopped the Phase 3 clinical trial early after an interim analysis showed that 7.3% of patients treated with the drug had died or were hospitalized, compared to double, 14.1% of those who received a placebo.
The decision to stop the study with the enrollment of new patients was made following a recommendation by an independent committee of scientists monitoring the study, after consulting the FDA because the pill was found to be very effective even before the trial period ended (studies are suspended early when the result is clearly positive and for ethical reasons the drug cannot be denied to patients who have been given placebo, as it was in this case, or on the contrary when the results are not as promising as would have been expected and it is considered useless to continue). The trial was interrupted for “overwhelming effectiveness” and it was at that point ethically unacceptable to deprive control patients of the benefit deriving from molnupiravir writes Roberto Burioni on twitter.
Phase 3 interim analysis of data from 775 patients showed that none of the participants who received molnupiravir died during the first 29 days of the study compared with eight who received placebo. Treatment involves one pill twice a day prescribed for five days to patients with a recent diagnosis of Covid-19. There were no particular problems regarding adverse events. Indeed, the incidence of each adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). At the same time, the incidence of drug-related adverse events was comparable (12% and 11%, respectively).
The drug has shown consistent efficacy on multiple coronavirus variants, including the highly transmissible Delta strain, according to MSD. notable being the first oral antiviral in the outpatient setting to show a benefit, he commented Nick Kartsonis, senior vice president of clinical research at Merck. The antiviral was produced in partnership with Ridgeback Biotherapeutics, a family-owned Miami company. The pharmaceutical company has announced that it expects to produce 10 million treatment cycles by the end of the year. The US government has signed an agreement to obtain approximately 1.7 million.
Early stages of infections
Molnupiravir has been studied in patients who tested positive for Covid within the first five days of symptoms, who also had at least one risk factor such as old age, obesity or diabetes. According to the note, the drug is particularly effective if used during the early stages of infection. Time in diagnosis appears to be critical: a previous study of molnupiravir in hospitalized patients was stopped after disappointing results. However, such a rapid diagnosis is not taken for granted, especially in countries where the circulation of the virus is very high and the diagnostic system is in crisis (even in Italy in critical periods the results of the swabs arrived after days). Furthermore, it is not even automatic that a patient at the onset of symptoms undergoes a swab immediately.
How does it work
Contrary to the main vaccines currently administered against Covid-19, the Merck’s drug does not target the virus’s spike protein, highly mutagenic, and should therefore maintain constant efficacy regardless of variants. Molnupivarir acts against the viral polymerase, an enzyme that the new coronavirus needs to replicate within the body. The drug was developed to introduce errors in the genetic code of the virus, thus preventing its duplication. Antiviral therapies that can be taken at home without hospitalization of the patient – he explained Wendy Holman, managing director of Ridgeback Biotherapeutics – represent a key therapeutic option today. We are proud.
The other antivirals
So far the only treatments available to cure Covid-19 are the expensive monoclonal antibodies produced by Regeneron, Eli Lilly and GlaxoSmithKline, which are administered intravenously and have been shown to be highly effective: studies have shown that they reduce hospitalizations and deaths by 70 to 85% in high-risk Covid patients, so they are more effective than the Merck pill. However, the arrival of an antiviral pill, in addition to the increasingly massive vaccination coverage, considered by experts to be a fundamental step in the fight to end the pandemic because easily administered compared to monoclonals that require hospitalization. In the coming months, results of the late stage study of two more antiviral pills, one developed by Pfizer and the other from Atea Pharmaceuticals and Roche.
Pfizer has started a medium to long-term study to test its oral drug for the prevention of Covid-19 among those exposed to the virus that aims to prevent the disease from becoming serious. The company will study the oral drug on 2,660 healthy adults living with a Sars CoV-2 positive family member. The experiment tested the effectiveness of a low dose of the active ingredient ritonavir, an older drug used in combination with other medicines to treat HIV. The company also said it has initiated a mid-to-late phase study of ritonavir for the treatment of Covid-19 in non-hospitalized symptomatic adult patients.
Roche instead studied Ronapreve, anti-Covid treatment, in hospitalized patients. From the phase II-III results released by Roche, Ronapreve significantly reduced viral load within seven days of treatment in patients who did not develop a natural immune response
If licensed, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused but the most recent studies have suggested that it offers only modest benefit for Covid patients.
October 1, 2021 (change October 5, 2021 | 08:08)
© REPRODUCTION RESERVED
The antiviral molnupiravir, according to Merck-MSD, halves the risk of hospitalization and death. Burioni: The trial was stopped due to overwhelming effectiveness. The pharmaceutical company will ask for authorization for emergency use
Impressive results. This is how immunologist and White House consultant Anthony Fauci comments on the data of the anti Covid pill developed by the pharmaceutical company Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics. Results that have aroused great enthusiasm around the world because the drug molnupiravir would be able to reduce the risk of hospitalization and death from Covid by 50% in unvaccinated Sars-CoV2 positive subjects treated within five days of starting symptoms. The pharmaceutical company said in a statement that it will ask the US FDA and then other regulatory bodies around the world for authorization. for emergency use of the pill antiviral molnupiravir for the treatment of Covid after an advanced clinical trial showed that the drug has in fact halved the risk of hospitalization and death.
The pharmaceutical company announced it had stopped the Phase 3 clinical trial early after an interim analysis showed that 7.3% of patients treated with the drug had died or were hospitalized, compared to double, 14.1% of those who received a placebo.
The decision to stop the study with the enrollment of new patients was made following a recommendation by an independent committee of scientists monitoring the study, after consulting the FDA because the pill was found to be very effective even before the trial period ended (studies are suspended early when the result is clearly positive and for ethical reasons the drug cannot be denied to patients who have been given placebo, as it was in this case, or on the contrary when the results are not as promising as would have been expected and it is considered useless to continue). The trial was interrupted for “overwhelming effectiveness” and it was at that point ethically unacceptable to deprive control patients of the benefit deriving from molnupiravir writes Roberto Burioni on twitter.
Phase 3 interim analysis of data from 775 patients showed that none of the participants who received molnupiravir died during the first 29 days of the study compared with eight who received placebo. Treatment involves one pill twice a day prescribed for five days to patients with a recent diagnosis of Covid-19. There were no particular problems regarding adverse events. Indeed, the incidence of each adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). At the same time, the incidence of drug-related adverse events was comparable (12% and 11%, respectively).
The drug has shown consistent efficacy on multiple coronavirus variants, including the highly transmissible Delta strain, according to MSD. notable being the first oral antiviral in the outpatient setting to show a benefit, he commented Nick Kartsonis, senior vice president of clinical research at Merck. The antiviral was produced in partnership with Ridgeback Biotherapeutics, a family-owned Miami company. The pharmaceutical company has announced that it expects to produce 10 million treatment cycles by the end of the year. The US government has signed an agreement to obtain approximately 1.7 million.
Early stages of infections
Molnupiravir has been studied in patients who tested positive for Covid within the first five days of symptoms, who also had at least one risk factor such as old age, obesity or diabetes. According to the note, the drug is particularly effective if used during the early stages of infection. Time in diagnosis appears to be critical: a previous study of molnupiravir in hospitalized patients was stopped after disappointing results. However, such a rapid diagnosis is not taken for granted, especially in countries where the circulation of the virus is very high and the diagnostic system is in crisis (even in Italy in critical periods the results of the swabs arrived after days). Furthermore, it is not even automatic that a patient at the onset of symptoms undergoes a swab immediately.
How does it work
Contrary to the main vaccines currently administered against Covid-19, the Merck’s drug does not target the virus’s spike protein, highly mutagenic, and should therefore maintain constant efficacy regardless of variants. Molnupivarir acts against the viral polymerase, an enzyme that the new coronavirus needs to replicate within the body. The drug was developed to introduce errors in the genetic code of the virus, thus preventing its duplication. Antiviral therapies that can be taken at home without hospitalization of the patient – he explained Wendy Holman, managing director of Ridgeback Biotherapeutics – represent a key therapeutic option today. We are proud.
The other antivirals
So far the only treatments available to cure Covid-19 are the expensive monoclonal antibodies produced by Regeneron, Eli Lilly and GlaxoSmithKline, which are administered intravenously and have been shown to be highly effective: studies have shown that they reduce hospitalizations and deaths by 70 to 85% in high-risk Covid patients, so they are more effective than the Merck pill. However, the arrival of an antiviral pill, in addition to the increasingly massive vaccination coverage, considered by experts to be a fundamental step in the fight to end the pandemic because easily administered compared to monoclonals that require hospitalization. In the coming months, results of the late stage study of two more antiviral pills, one developed by Pfizer and the other from Atea Pharmaceuticals and Roche.
Pfizer has started a medium to long-term study to test its oral drug for the prevention of Covid-19 among those exposed to the virus that aims to prevent the disease from becoming serious. The company will study the oral drug on 2,660 healthy adults living with a Sars CoV-2 positive family member. The experiment tested the effectiveness of a low dose of the active ingredient ritonavir, an older drug used in combination with other medicines to treat HIV. The company also said it has initiated a mid-to-late phase study of ritonavir for the treatment of Covid-19 in non-hospitalized symptomatic adult patients.
Roche instead studied Ronapreve, anti-Covid treatment, in hospitalized patients. From the phase II-III results released by Roche, Ronapreve significantly reduced viral load within seven days of treatment in patients who did not develop a natural immune response
If licensed, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused but the most recent studies have suggested that it offers only modest benefit for Covid patients.
October 1, 2021 (change October 5, 2021 | 08:08)
© REPRODUCTION RESERVED
The antiviral molnupiravir, according to Merck-MSD, halves the risk of hospitalization and death. Burioni: The trial was stopped due to overwhelming effectiveness. The pharmaceutical company will ask for authorization for emergency use
Impressive results. This is how immunologist and White House consultant Anthony Fauci comments on the data of the anti Covid pill developed by the pharmaceutical company Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics. Results that have aroused great enthusiasm around the world because the drug molnupiravir would be able to reduce the risk of hospitalization and death from Covid by 50% in unvaccinated Sars-CoV2 positive subjects treated within five days of starting symptoms. The pharmaceutical company said in a statement that it will ask the US FDA and then other regulatory bodies around the world for authorization. for emergency use of the pill antiviral molnupiravir for the treatment of Covid after an advanced clinical trial showed that the drug has in fact halved the risk of hospitalization and death.
The pharmaceutical company announced it had stopped the Phase 3 clinical trial early after an interim analysis showed that 7.3% of patients treated with the drug had died or were hospitalized, compared to double, 14.1% of those who received a placebo.
The decision to stop the study with the enrollment of new patients was made following a recommendation by an independent committee of scientists monitoring the study, after consulting the FDA because the pill was found to be very effective even before the trial period ended (studies are suspended early when the result is clearly positive and for ethical reasons the drug cannot be denied to patients who have been given placebo, as it was in this case, or on the contrary when the results are not as promising as would have been expected and it is considered useless to continue). The trial was interrupted for “overwhelming effectiveness” and it was at that point ethically unacceptable to deprive control patients of the benefit deriving from molnupiravir writes Roberto Burioni on twitter.
Phase 3 interim analysis of data from 775 patients showed that none of the participants who received molnupiravir died during the first 29 days of the study compared with eight who received placebo. Treatment involves one pill twice a day prescribed for five days to patients with a recent diagnosis of Covid-19. There were no particular problems regarding adverse events. Indeed, the incidence of each adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). At the same time, the incidence of drug-related adverse events was comparable (12% and 11%, respectively).
The drug has shown consistent efficacy on multiple coronavirus variants, including the highly transmissible Delta strain, according to MSD. notable being the first oral antiviral in the outpatient setting to show a benefit, he commented Nick Kartsonis, senior vice president of clinical research at Merck. The antiviral was produced in partnership with Ridgeback Biotherapeutics, a family-owned Miami company. The pharmaceutical company has announced that it expects to produce 10 million treatment cycles by the end of the year. The US government has signed an agreement to obtain approximately 1.7 million.
Early stages of infections
Molnupiravir has been studied in patients who tested positive for Covid within the first five days of symptoms, who also had at least one risk factor such as old age, obesity or diabetes. According to the note, the drug is particularly effective if used during the early stages of infection. Time in diagnosis appears to be critical: a previous study of molnupiravir in hospitalized patients was stopped after disappointing results. However, such a rapid diagnosis is not taken for granted, especially in countries where the circulation of the virus is very high and the diagnostic system is in crisis (even in Italy in critical periods the results of the swabs arrived after days). Furthermore, it is not even automatic that a patient at the onset of symptoms undergoes a swab immediately.
How does it work
Contrary to the main vaccines currently administered against Covid-19, the Merck’s drug does not target the virus’s spike protein, highly mutagenic, and should therefore maintain constant efficacy regardless of variants. Molnupivarir acts against the viral polymerase, an enzyme that the new coronavirus needs to replicate within the body. The drug was developed to introduce errors in the genetic code of the virus, thus preventing its duplication. Antiviral therapies that can be taken at home without hospitalization of the patient – he explained Wendy Holman, managing director of Ridgeback Biotherapeutics – represent a key therapeutic option today. We are proud.
The other antivirals
So far the only treatments available to cure Covid-19 are the expensive monoclonal antibodies produced by Regeneron, Eli Lilly and GlaxoSmithKline, which are administered intravenously and have been shown to be highly effective: studies have shown that they reduce hospitalizations and deaths by 70 to 85% in high-risk Covid patients, so they are more effective than the Merck pill. However, the arrival of an antiviral pill, in addition to the increasingly massive vaccination coverage, considered by experts to be a fundamental step in the fight to end the pandemic because easily administered compared to monoclonals that require hospitalization. In the coming months, results of the late stage study of two more antiviral pills, one developed by Pfizer and the other from Atea Pharmaceuticals and Roche.
Pfizer has started a medium to long-term study to test its oral drug for the prevention of Covid-19 among those exposed to the virus that aims to prevent the disease from becoming serious. The company will study the oral drug on 2,660 healthy adults living with a Sars CoV-2 positive family member. The experiment tested the effectiveness of a low dose of the active ingredient ritonavir, an older drug used in combination with other medicines to treat HIV. The company also said it has initiated a mid-to-late phase study of ritonavir for the treatment of Covid-19 in non-hospitalized symptomatic adult patients.
Roche instead studied Ronapreve, anti-Covid treatment, in hospitalized patients. From the phase II-III results released by Roche, Ronapreve significantly reduced viral load within seven days of treatment in patients who did not develop a natural immune response
If licensed, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused but the most recent studies have suggested that it offers only modest benefit for Covid patients.
October 1, 2021 (change October 5, 2021 | 08:08)
© REPRODUCTION RESERVED
The antiviral molnupiravir, according to Merck-MSD, halves the risk of hospitalization and death. Burioni: The trial was stopped due to overwhelming effectiveness. The pharmaceutical company will ask for authorization for emergency use
Impressive results. This is how immunologist and White House consultant Anthony Fauci comments on the data of the anti Covid pill developed by the pharmaceutical company Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics. Results that have aroused great enthusiasm around the world because the drug molnupiravir would be able to reduce the risk of hospitalization and death from Covid by 50% in unvaccinated Sars-CoV2 positive subjects treated within five days of starting symptoms. The pharmaceutical company said in a statement that it will ask the US FDA and then other regulatory bodies around the world for authorization. for emergency use of the pill antiviral molnupiravir for the treatment of Covid after an advanced clinical trial showed that the drug has in fact halved the risk of hospitalization and death.
The pharmaceutical company announced it had stopped the Phase 3 clinical trial early after an interim analysis showed that 7.3% of patients treated with the drug had died or were hospitalized, compared to double, 14.1% of those who received a placebo.
The decision to stop the study with the enrollment of new patients was made following a recommendation by an independent committee of scientists monitoring the study, after consulting the FDA because the pill was found to be very effective even before the trial period ended (studies are suspended early when the result is clearly positive and for ethical reasons the drug cannot be denied to patients who have been given placebo, as it was in this case, or on the contrary when the results are not as promising as would have been expected and it is considered useless to continue). The trial was interrupted for “overwhelming effectiveness” and it was at that point ethically unacceptable to deprive control patients of the benefit deriving from molnupiravir writes Roberto Burioni on twitter.
Phase 3 interim analysis of data from 775 patients showed that none of the participants who received molnupiravir died during the first 29 days of the study compared with eight who received placebo. Treatment involves one pill twice a day prescribed for five days to patients with a recent diagnosis of Covid-19. There were no particular problems regarding adverse events. Indeed, the incidence of each adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). At the same time, the incidence of drug-related adverse events was comparable (12% and 11%, respectively).
The drug has shown consistent efficacy on multiple coronavirus variants, including the highly transmissible Delta strain, according to MSD. notable being the first oral antiviral in the outpatient setting to show a benefit, he commented Nick Kartsonis, senior vice president of clinical research at Merck. The antiviral was produced in partnership with Ridgeback Biotherapeutics, a family-owned Miami company. The pharmaceutical company has announced that it expects to produce 10 million treatment cycles by the end of the year. The US government has signed an agreement to obtain approximately 1.7 million.
Early stages of infections
Molnupiravir has been studied in patients who tested positive for Covid within the first five days of symptoms, who also had at least one risk factor such as old age, obesity or diabetes. According to the note, the drug is particularly effective if used during the early stages of infection. Time in diagnosis appears to be critical: a previous study of molnupiravir in hospitalized patients was stopped after disappointing results. However, such a rapid diagnosis is not taken for granted, especially in countries where the circulation of the virus is very high and the diagnostic system is in crisis (even in Italy in critical periods the results of the swabs arrived after days). Furthermore, it is not even automatic that a patient at the onset of symptoms undergoes a swab immediately.
How does it work
Contrary to the main vaccines currently administered against Covid-19, the Merck’s drug does not target the virus’s spike protein, highly mutagenic, and should therefore maintain constant efficacy regardless of variants. Molnupivarir acts against the viral polymerase, an enzyme that the new coronavirus needs to replicate within the body. The drug was developed to introduce errors in the genetic code of the virus, thus preventing its duplication. Antiviral therapies that can be taken at home without hospitalization of the patient – he explained Wendy Holman, managing director of Ridgeback Biotherapeutics – represent a key therapeutic option today. We are proud.
The other antivirals
So far the only treatments available to cure Covid-19 are the expensive monoclonal antibodies produced by Regeneron, Eli Lilly and GlaxoSmithKline, which are administered intravenously and have been shown to be highly effective: studies have shown that they reduce hospitalizations and deaths by 70 to 85% in high-risk Covid patients, so they are more effective than the Merck pill. However, the arrival of an antiviral pill, in addition to the increasingly massive vaccination coverage, considered by experts to be a fundamental step in the fight to end the pandemic because easily administered compared to monoclonals that require hospitalization. In the coming months, results of the late stage study of two more antiviral pills, one developed by Pfizer and the other from Atea Pharmaceuticals and Roche.
Pfizer has started a medium to long-term study to test its oral drug for the prevention of Covid-19 among those exposed to the virus that aims to prevent the disease from becoming serious. The company will study the oral drug on 2,660 healthy adults living with a Sars CoV-2 positive family member. The experiment tested the effectiveness of a low dose of the active ingredient ritonavir, an older drug used in combination with other medicines to treat HIV. The company also said it has initiated a mid-to-late phase study of ritonavir for the treatment of Covid-19 in non-hospitalized symptomatic adult patients.
Roche instead studied Ronapreve, anti-Covid treatment, in hospitalized patients. From the phase II-III results released by Roche, Ronapreve significantly reduced viral load within seven days of treatment in patients who did not develop a natural immune response
If licensed, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused but the most recent studies have suggested that it offers only modest benefit for Covid patients.
October 1, 2021 (change October 5, 2021 | 08:08)
© REPRODUCTION RESERVED