Amid criticism for its handling of another Alzheimer’s disease drug, the FDA will decide this week whether to approve lecanemab

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Jaymy Lee

Eisai and Bioen’s lecanemab helped slow the progression of Alzheimer’s disease in a clinical trial

The Food and Drug Administration is set to make a decision on whether to approve a new Alzheimer’s disease drug the week after a damning new report revealed the regulator failed to follow the correct procedures when it approved another treatment for Alzheimer’s disease in 2021.

A study published in the New England Journal of Medicine in November found that Eisai and Biogen’s lecanemab (BIIB) moderately slowed the progression of Alzheimer’s disease in 1,795 patients in a Phase 3 clinical trial out of 18 month. The data, which was released this fall, also delighted Wall Street and the medical community.

“This is kind of the dawn of a new era in Alzheimer’s disease drug development,” Dr. Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation, told MarketWatch in December. .

The drug is awaiting expedited approval, with the FDA expected to make its decision on Friday or by Friday. The companies said they also plan to gain full approval for the therapy.

The timing of the expedited approval scheduled for this week is somewhat complicated. A highly critical congressional report released last week found that the FDA and Biogen worked together in an “inappropriate” and “atypical” way on documents that helped support the approval of Aduhelm, a controversial treatment for the disease. Alzheimer’s disease developed and marketed by the same companies.

The report also took aim at Aduhelm’s price, with lawmakers saying the initial price of $56,000 was intended to “make history” for Biogen by delivering one of the most successful pharmaceutical launches of all time. The company eventually dropped the price to $28,200, though that did little to guarantee the use of a therapy that some hospitals refused to use and Medicare refused to cover unless patients do participate 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 different? Well, Eisai, not Biogen, is taking the lead in the regulatory process and bringing the new drug to market 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’s also a competitor behind the scenes – Eli Lilly’s donanemab (LLY), another treatment candidate for removing amyloid plaque that’s currently in Phase 3 clinical trials for Alzheimer’s disease patients in early stage. Lilly told investors in December that it plans to launch donanemab later this year.

Shares of Biogen are up 11.8% over the past 12 months, while shares of Eisai have gained 31.5%.

-Jaimy Lee

(END) Dow Jones Newswire

01-05-23 0742ET

Copyright (c) 2023 Dow Jones & Company, Inc.

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