The drug, known as aducanumab, is the first Alzheimer's treatment approved by the FDA in almost 20 years. It will be marketed as Aduhelm. Biogen is also charging $56,000 per year for aducanumab. It is meant to be given as an infusion every four weeks.
The FDA approved the drug based on the results of studies that showed it seemed "reasonably likely" to benefit Alzheimer's patients. It is also the only therapy that regulators have said can likely treat the disease, rather than just manage its symptoms.
Analysts say the FDA's decision is certain to spark disagreements among doctors, patient groups and scientists. The decision also has far-reaching implications for the standards that federal regulators use to evaluate experimental drugs, including those that offer minimal benefits despite claims to the contrary.
Patients and their families are beginning to inquire about the new drug following the FDA's approval. In fact, it is expected to start arriving in hospitals in just a few weeks. About 900 hospitals and medical facilities in the U.S. are ready to begin prescribing aducanumab to Alzheimer's patients.
However, there is serious division about the drug within the FDA. Last November, an FDA advisory committee, which was comprised of experts outside the agency, concluded that there wasn't enough evidence to support approval of the drug. Joel Perlmutter, a neurologist at the Washington University School of Medicine who was one of the eight panelists, said they risk delaying good, effective treatments if they approve a drug without data that is reliable.
Caleb Alexander of Johns Hopkins University, another panelist who voted against approving the novel drug, said he was surprised and disappointed by the FDA's decision. The FDA gets the respect that it does because of its science-based regulatory standards, he said. "In this case, I think they gave the product a pass."
Biogen's shares increased 38 percent in trading on Monday following the news of the FDA's approval. Many analysts are forecasting billions in future sales for the company. The FDA's greenlight is also expected to revive investments in Alzheimer's treatments, both new ones and those previously shelved by drug makers.
This has led some experts to believe that Biogen is banking on aducanumab to increase its revenue following the decline of its multiple sclerosis drug Tecfidera. Tecfidera raked in more than a third of Biogen's overall sales for the past eight years. But it is now becoming less popular after generic versions of the drug were introduced to the U.S. market in 2020.
Given the debate surrounding aducanumab, some doctors are on the fence about whether to prescribe the drug to patients with Alzheimer's disease. Jason Karlawish, a professor of medicine at the University of Pennsylvania, said he wouldn't prescribe it even if it were approved on an op-ed piece posted Sunday, May 30.
Karlawish said Biogen simply hasn't made a convincing case for the drug. Worse, the FDA's approval may have very disturbing consequences. Roughly two million Americans could be prescribed aducanumab at an estimated cost that ranges anywhere between $20,000 to $50,000 per person per year.
According to Karlawish, the few drugs he prescribes are only moderately effective in easing the cognitive issues brought on by Alzheimer's. None of the drugs actually slow the condition's brain-destroying effect. (Related: The therapeutic effects of ginseng against Alzheimer’s disease.)
Even if Biogen had clear, compelling data about the efficacy of aducanumab, Karlawish said the drug's benefits remain ambiguous at best and not worth the cost. "Putting it on the market will stress Medicare’s resources."
Learn more about other controversial drugs that the FDA approved for use at FDA.news.