FDA, under fire for Aduhelm approval, starts review of another Alzheimer’s drug

Dive Brief:

• Biogen and Eisai’s lecanemab, an experimental treatment for Alzheimer’s disease, will get a Food and Drug Administration decision on accelerated approval by Jan. 6, 2023, the companies announced Tuesday. The partners asked for clearance based on biological data from completed trials, although they expect this fall to have results from a study that will assess whether lecanemab can slow disease progression. 
• The FDA’s new deadline would follow by about 19 months its controversial call to grant a speedy approval to another Biogen Alzheimer’s drug, Aduhelm — a decision that hinged on the therapy’s ability to reduce accumulations of a toxic protein in the brains of patients. Mixed clinical results, though, have kept insurers from paying for Aduhelm for the most part, including the Medicare program for the elderly.
• The Aduhelm rollout has pushed Biogen to shelve marketing plans and some research aimed at confirming the drug’s benefit. The company is also laying off employees and searching for new leadership. Accelerated approval of lecanemab could provide a welcome boost, although the drug may face the same coverage obstacles that have slowed Aduhelm.

Dive Insight:

By the end of the year, FDA officials should be reviewing two new experimental drugs that act similarly to Aduhelm.

Besides lecanemab, Eli Lilly has indicated that a submission for its candidate, donanemab, should be delivered to the agency by the end of 2022. These filings will likely force the agency to make some tough choices about the next wave of Alzheimer’s medicines. The FDA’s decision to approve Aduhelm in spite of mixed supporting data, as well as a negative vote from outside advisers, triggered scrutiny from Congress and federal investigators.

The three drugs, along with two other projects being developed by Roche, work by binding to various forms of that toxic brain protein, called amyloid beta. By breaking up and removing amyloid beta, drug developers hope to slow or even stop the progressive loss of cognitive skills and physical function experienced by Alzheimer’s patients. Yet, several drugs targeting this protein have already failed to help patients, including one called bapineuzumab and another called solanezumab, which Lilly developed. 

The FDA granted lecanemab “priority review,” setting a six-month evaluation period once the agency had certified that Biogen and Eisai completed all the documentation to support the drug. The agency typically takes up to 10 months to review a standard approval application.

To justify accelerated approval, the companies presented data from more than 800 patients showing that use of lecanemab significantly reduced amyloid accumulation and had an effect on measures of cognition. The study missed its primary goal, however.

In addition to granting priority review of its accelerated approval request, the FDA said a Phase 3 confirmatory trial called Clarity-AD is already underway in patients with symptomatic early Alzheimer’s disease. Biogen and Eisai noted, too, that positive study results would help support the conversion of an accelerated approval to a full one.

That 1,795-patient study completed enrollment in March 2021, and data are expected this fall. If positive, Biogen and Eisai said the data will be submitted to the FDA no later than March 31, 2023.

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