The US Food and Drug Administration, Thursday, officially authorized the use of an Alzheimer’s disease drug developed by the Japanese “Eisai” pharmaceutical company and the US “Biogen” company, thus becoming the first drug in the world shown to slow the early stages of the degenerative brain disease.
According to the Japanese Kyodo News Agency, the Food and Drug Administration has authorized the new drug, known chemically as “likanimab”, which can reduce the amount of sticky brain protein called “amyloid beta”, which experts see as a hallmark of the disease.
It is noteworthy that the treatment with the drug, which Esay expects to cost the patient $ 26,500 annually before insurance coverage, will begin to be provided to patients who suffer from mild cognitive impairment or who have entered the stage of mild dementia.
The Japanese drugmaker also said that between 13% and 17% of those who received the drug experienced side effects, such as brain edema and bleeding.
However, she said most of the side effects were mild to moderate and that the symptoms were temporary.
The Food and Drug Administration granted fast-track conditional approval for the drug in early January, based on the observed decreases in the level of a toxic protein that builds up in the human brain.
To obtain full approval, drug manufacturers were required to provide additional data to the agency to review the drug’s safety and clinical benefits.
And with the US Food and Drug Administration now granting traditional approval to the drug, which is branded “Lekembe,” patients under the US federal government’s Medicare insurance program can get more access to the treatment.
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