An FDA official claims that Biogen’s ALS medication may have “clinical benefit” for uncommon illness types.

Despite failing in a larger, late-stage clinical trial last year, Biogen’s experimental medicine ALS has demonstrated “clinical benefit” to rare and aggressive disorders, according to U.S. Food and medicine Administration officials on Monday. said that it might result in Attending a meeting on Wednesday is the staff’s decision about the recommendation of an external adviser panel to approve Biogen’s drug Tofersen for the treatment of a rare genetic form of amyotrophic lateral sclerosis (ALS) as soon as possible. The goal of the FDA’s expedited approval status is to enable quicker approval of medications for serious illnesses that meet unmet medical requirements. The panel will decide on whether Tofersen exhibits a therapeutic benefit in patients with rare ALS after reviewing the extensive body of data from trials pertaining to the medication’s efficacy and safety. FDA