The Food and Drug Administration (FDA), the US regulatory agency, authorized on Wednesday a drug against Covid-19 produced by pharmaceutical company Pfizer. The drug, called Paxlovid, is the first antiviral pill against the disease approved in the country.
The drug has been authorized for patients aged 12 years and over who are more vulnerable to severe cases of Covid-19 due to factors such as obesity, diabetes or old age.
Data from Pfizer’s clinical trials indicate that treatment with the oral drug can reduce the risk of hospitalizations and deaths among high-risk patients by up to 89%. The latest data confirm that the drug is a “potent inhibitor” of the omicron variant.
The antiviral pill is combined with a low dose of an HIV drug called ritonavir.
As treatment with Pfizer pills can be carried out simply and without the patient leaving home, it is expected that the drug will become a crucial tool in the fight against the pandemic, at a time when the micron, the most contagious variant coronavirus and dominant in the US, caused the number of cases to soar.
Until now, all treatments for Covid-19 allowed in the US used drugs given by injections or intravenously.
The treatment should start within a maximum period of five days after the onset of symptoms, and to buy it you will need to present a prescription.
The pill, which must be taken twice a day for about five days, blocks the activity of a specific enzyme that the coronavirus needs to replicate in the human body, a mechanism similar to that of the drug developed by drugmaker MSD.
Pfizer said it is ready to begin immediate distribution of its tablets and has increased production from 80 million to 120 million units by next year.
Generics
In November, Pfizer announced an agreement that will allow Paxlovid to be produced and sold at low prices in 95 low- and middle-income countries. The agreement between the pharmaceutical company and Unitaid, a partner of the World Health Organization (WHO) in health emergencies, provides for the production of generic pills to make them more accessible to the global population. Pfizer will not receive patent rights for generic production as long as WHO upholds Covid-19’s declaration of an international health emergency.
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