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The Food and Drug Administration is expected to make a decision on whether to approve a new Alzheimer’s disease medication the week after a damning new report found the regulator didn’t follow the correct procedures when it approved another Alzheimer’s treatment in 2021.
A study published in the New England Journal of Medicine in November found that Eisai
4523,
and Biogen’s
BIIB,
lecanemab moderately slowed the progression of Alzheimer’s among 1,795 patients who participated in a Phase 3 clinical trial over 18 months. The data, which trickled out this fall, equally thrilled Wall Street and the medical community.
“It’s sort of the dawn of a new era in Alzheimer’s drug development,” Dr. Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation, told MarketWatch in December.
The drug is up for accelerated approval, with the FDA required to make its decision on or by Friday. The companies have said they plan to seek full approval for the therapy as well.
The timing of this week’s anticipated accelerated approval is somewhat complicated. A highly critical congressional report published last week found that the FDA and Biogen worked together in an “inappropriate” and “atypical” manner on documents that helped support the approval of Aduhelm, a controversial Alzheimer’s treatment developed and marketed by the same companies.
The report also took aim at how Aduhelm was priced, with lawmakers saying the original $56,000 price tag was intended to “make history” for Biogen by having one of the most successful pharmaceutical launches of all time. The company eventually lowered the price to $28,200, though that did little to ensure utilization of a therapy that some hospitals refused to use and Medicare declined to cover unless patients participated in clinical trials.
Aduhelm, now considered a failure, generated less than $5 million in sales in the first three quarters of 2022.
Will lecanemab be any different? Well, Eisai, not Biogen, is taking the lead on the regulatory process and marketing for the new medication if it’s approved, and the Japanese drugmaker has already hinted at how it plans to price lecanemab, saying the value-based price of the drug is between $9,200 and $35,600.
There is also a competitor in the wings — Eli Lilly’s
LLY,
donanemab, another amyloid plaque-clearing treatment candidate that is currently in Phase 3 clinical trials for patients with early Alzheimer’s. Lilly told investors in December it expects to launch donanemab sometime this year.
Biogen’s stock is up 11.8% over the last 12 months, while Eisai’s shares have gained 31.5%.
