The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic...
The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s BIIB torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or ALS. The accelerated approval program is used to OK drugs for serious conditions with an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.
The accelerated approval program is used to OK drugs for serious conditions with an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients. In this instance, it’s for patients suffering from SOD1-ALS, a progressive neurodegenerative disease that attacks and kills the nerve cells that control voluntary muscles.
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