When it comes to the Alzheimer’s disease med Aduhelm, Biogen can’t seem to catch a break. Alongside meager sales and a stifling Medicare coverage proposal, the drug is now bound for more scrutiny under a pair of US government probes.
The Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) have launched two separate investigations into Biogen and its troubled Alzheimer’s med, the company revealed in an annual securities filing Thursday.
The FTC has made a civil investigative demand—a type of administrative subpoena—in pursuit of documents related to Aduhelm’s marketing and approval, plus healthcare sites, the company said.
The SEC, meanwhile, has launched a separate inquiry that also seeks marketing and approval information on the beleaguered anti-amyloid antibody.
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Biogen won’t accelerated approval for Aduhelm last summer, but the FDA based its decision on a surrogate endpoint—the removal of amyloid plaques—rather than a slowing cognitive decline. The FDA’s decision also went in the face of a resounding ‘no’ from the advisory committee that met on Aduhelm’s approval.
This isn’t the first Aduhelm investigation, either. In June, the House Committee on Oversight and Reform said it was launching a probe into the drug’s controversial approval and pricing. Biogen originally priced the drug at $56,000, but eventually slashed the cost to $28,200 for a patient of average weight.
The lawmakers have also asked the FDA to produce additional data and documentation supporting its accelerated approval for the drug. The FDA, meanwhile, is its own investigation into the drug, Endpoints notes.
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Aduhelm’s rocky rollout has been translated into poor sales, too. The drug made just $1 million for the fourth quarter and $3 million for all of 2021, Biogen reported Thursday. That pales in comparison to the hundreds of millions of dollars in selling, general and administrative expenses the company has recorded on the beleaguered medicine so far.