Member of FDA panel resigns over approval of Biogen’s Alzheimer’s drug

June 14, 2021: -A third member of a key Food and Drug Administration advisory panel has resigned over the controversial decision of the agency to approve Biogen’s new Alzheimer’s drug, Aduhelm, according to CNBC.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid will help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he said.

Shares of Biogen surged 38% on Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow the cognitive decline in people with Alzheimer’s, and the first medicine for the disease in almost two decades.

Biogen’s drug targets a “sticky” compound in the brain called beta-amyloid, which scientists expect plays a role in the devastating disease.

The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer’s patients. The agency then approved on the condition that Biogen conducts another clinical trial.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the committee also criticized agency staff for what it called an overly optimistic review of the data.

In March 2019, Biogen pulled the development of the drug after an analysis from an independent group which revealed it was unlikely to work. The company then shocked investors after a few months by announcing it would seek regulatory approval for the drug after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of the biggest dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Experts of Alzheimer’s and Wall Street analysts were skeptical immediately, with some wondering if the clinical trial data was enough to prove the drug works and if approval could make it harder for other companies to enroll patients in their drug trials.