Biogen Defends Controversial Alzheimer’s Drug as FDA Calls for Probe

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Biogen’s new — and controversial — Alzheimer’s drug, Adhulem, made a modest $2 million in revenue in the first several weeks after its approval on June 7th, the company announced Thursday.

Biogen also surprised many by launching a defiant PR offensive: its head of research, Dr. Al Sandrock took the unusual step of releasing an open letter alongside the earnings report, accusing critics of the drug of “extensive misinformation and misunderstanding.”

Short on Data, Long on Drama

Aduhelm, the first FDA-approved Alzheimer’s drug in 20 years, has become a source of controversy since scientists and researchers have raised concerns about the research behind it.

Two late-stage clinical trials were shut down in 2019 when an independent panel concluded the drug wasn’t helping patients. Biogen later conducted its own analysis and found that high-dosage patients in just one trial showed a very small reduction in cognitive decline. While admitting there was no hard evidence on the drug’s merits, the U.S. Food and Drug Administration gave aduhelm the go-ahead anyway:

  • As a result, patients are now forking over $56,000 a year for the infusion treatment. The FDA used an “accelerated approval,” which allows the regulator to greenlight unproven treatments for serious diseases to make them available sooner for patients in need.
  • Meanwhile, three members of the FDA’s independent panel of outside experts — who refused to endorse aduhelm last fall on the basis that the data was insufficient — have resigned in protest since the agency approved the drug.

“This approval shouldn’t have happened,” Dr. Vissia Viglietta, Biogen’s former senior medical director who helped design the drug’s two clinical trials, told the New York Times. “It defeats everything I believe in scientifically and it lowers the rigor of regulatory bodies.”

Call In The Detectives: With the temperature being turned up on the agency, Acting FDA Commissioner Dr. Janet Woodcock, who was not involved in the approval decision, has asked the Office of the Inspector General to conduct an investigation into her agency over the matter. Biogen says it welcomes a probe.

Priced In: None of these developments are hurting Biogen’s bottom line. While its second-quarter sales slid to $2.8 billion (a 25% decline compared to last year), the company still beat expectations of $2.6 billion. And its shares rose 1.4% on Thursday.