New hope for Alzheimer's patients
FDA Approval of Biogen's Aduhelm brings new hope to Alzheimer's patients
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
On June 7th, 2021, the FDA has granted the accelerated approval for Biogen's aducanumab ( known by the brand name Aduhelm ), the first Alzheimer's treatment that has shown evidence in clinical trials of reducing amyloid plaque in the brain and slowing cognitive decline. Before aducanumab, nearly every effort to treat Alzheimer’s had failed, even as the number of Americans living with the disorder swelled past 6 million. The last approved drug came in 2003 and only temporarily boosts memory.
While this approval is welcoming news to the Alzheimer's community, it doesn't come without controversies.
First, the agency advisory committee voted nearly unanimously in November 2020 that Biogen's drug should not be approved, citing inconclusive evidence. FDA proceeded with the authorization despite its advisors' concerns. As a result, three members of the advisory committee have resigned after the agency's decision.
Second, Biogen has priced Aduhelm at $56,000, a seemingly high price for a drug that has demonstrated little efficacy.
Despite these controversies, we think the agency has taken a bold yet innovative move. By approving Aduhelm at the current price, the FDA has signaled a total addressable market worth billions. Such a move would attract new entrants, spur innovation, deliver more treatment options, and ultimately bring new hope to Alzheimer's patients and their families.
MS ( Multiple Sclerosis ) provides a good example. It was 1993 when the FDA approved the first treatment for multiple sclerosis. Now patients have some two dozen options, which can treat different forms of the disease, significantly slow progression, and reduce flare-ups.
With our mission of making healthcare accessible to all, we at Good AI are particularly excited by this free-market approach in bringing a new drug to the market. With enough entrants in the market, the price of Aduhelm would come down. And with tools such as value-based agreements where providers are being paid according to outcome/value, further price adjustment would take place. Alzheimer's drugs such as Aduhelm would ultimately become affordable.