Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing

After an accelerated approval early this year for Alzheimer's disease drug Leqembi, Eisai and Biogen are taking their important launch one step at a time. Now, amid those efforts, the FDA has given the partners a date on its regulatory calendar as they seek a potential full approval.

By July 6, barring any delays, the agency will decide whether to grant a full nod for Leqembi. But the FDA's decision will come after an advisory committee has its say on the application.

The agency has awarded a priority review for the Leqembi application, cutting several months from its usual review timeline. Leqembi scored its original nod in early January under the agency's accelerated approval pathway.

Eisai's new Leqembi application leverages data from a global phase 3 trial called Clarity AD. Those findings showed that the drug delivered a statistically significant reduction of cognitive decline compared with placebo.

Under Leqembi's current accelerated approval, Eisai is taking the launch slow as it awaits a potential full approval. Instead of a full launch right away, the company is getting infrastructure in place to prepare for a more aggressive rollout later.

That approach proved wise when the Centers for Medicare & Medicaid Services (CMS) last month denied wider coverage for the drug on Medicare. Like other drugs in the class, Leqembi can currently only be reimbursed in clinical trial settings, CMS ruled. 

The agency wants more data before changing its stance on the new class of monoclonal antibodies that target amyloid in the brain to fight Alzheimer's disease. CMS published its coverage rules last year in response to the controversy surrounding Leqembi's predecessor, Aduhelm.

As for Eisai, the company expected CMS to hold off on making any changes until a full approval. Until then, the company is “actively working” with CMS to “determine the most efficient path” to access, a spokesperson said last month.