FDA official says Biogen’s ALS drug may offer ‘clinical benefit’ in rare forms of disease

U.S. Food and Drug Administration officials said Monday that Biogen’s investigational drug ALS has shown “clinical benefit” to rare and aggressive diseases despite failing in a broader late-stage clinical trial last year. said that it could lead to Staff are at a meeting Wednesday to discuss whether a panel of external advisers should recommend early approval of Biogen’s drug Tofersen to treat a rare genetic form of amyotrophic lateral sclerosis (ALS). The FDA’s accelerated approval status is intended to allow more rapid approval of drugs for serious conditions that address unmet medical needs…………..