Home report questions FDA’s approval of Alzheimer’s drug

The congressional report provides the newest lens into the Aduhelm’s saga, which started after Biogen halted medical trials over disappointing ends in 2019. However the firm reversed course months later, arguing {that a} new evaluation revealed the drug’s potential profit.

The report labeled the FDA’s subsequent actions as “atypical” and “rife with irregularities,” pointing to undocumented interactions with Biogen and the preparation of an uncommon joint briefing doc for a key advisory committee.

That panel, the Peripheral and Central Nervous System Medication Advisory Committee, advisable the FDA reject the drug. However the company instantly okayed Aduhelm by means of the accelerated approval pathway — an possibility that was not offered to committee members. A number of resigned in protest.

The report additionally discovered the FDA initially granted Aduhelm a broad label for all Alzheimer’s sufferers, despite Biogen’s reservations over a scarcity of information on late-stage sufferers. However Biogen didn’t push again, and later requested the label be narrowed to simply early-stage instances after public backlash.

Consultants additionally raised issues concerning the drug’s potential to empty Medicare’s funds within the wake of its approval, due to its excessive price ticket. Inside paperwork obtained by the committees present Biogen calculated most affected person entry at roughly one-third of its preliminary $56,000 record value. The corporate additionally deliberate a four-year, $3.3 billion advertising technique.