FDA adcomm votes unanimously in favor of full approval for Eisai’s new Alzheimer’s drug

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee on Friday voted 6-0 in favor of fully approving Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), which first won an accelerated approval in January.

The full approval, expected on or before July 6, would open the door to wider insurance and Medicare coverage for those with mild cognitive impairment or mild dementia and confirmed presence of amyloid beta pathology but who could not or do not want to pay the $26,500 per year list price.

Merit Cudkowicz

Voting members at Friday’s meeting were all in favor of Leqembi’s positive risk-benefit profile. Panelist Merit Cudkowicz of Harvard Medical School said the evidence of Leqembi’s clinical benefit was clear and said she was impressed that the effect was seen early and that it increased with time.

“For an illness like this where they don’t have much, these are meaningful changes,” Cudkowicz said.

Adcomm panelist Tanya Simuni, professor of neurology at the Northwestern University Feinberg School of Medicine, said “the question that everyone is struggling” with is what the clinical meaningfulness is. “It’s an absolutely small delta,” Simuni said, but “that has to be put in context of the early stage of the disease.”

Chief panelist Robert Alexander, chief scientific officer at the Banner Alzheimer’s Institute, reiterated that overall, the company demonstrated clearly that this is an effective treatment in the population as it was defined. He also noted strong support among the panelists in general on Leqembi’s efficacy.

The positive vote follows positive results on a key placebo-controlled trial, known as CLARITY AD, showing Leqembi slowed the rate of cognitive and functional decline by 27% when compared to a placebo after 18 months. Literature and Alzheimer’s experts say that a 20-30% slowing of disease is clinically meaningful, Sharon Cohen, medical director at the Toronto Memory Program, said Friday during her presentation on Eisai’s behalf.

Side effects like brain swelling and brain bleeds were also cited but said to be controllable with close monitoring, FDA and Eisai noted.

Cudkowicz also asked the FDA what kind of data might be collected to inform uncertainties around the use of Leqembi. Teresa Buracchio, acting director of FDA’s Office of Neuroscience, pointed to certain safety surveillance measures under Leqembi’s accelerated approval, noting Eisai is required to submit expedited reports and collect more data on adverse events. There are also registries that are ongoing for lecanemab and Biogen’s other anti-amyloid drug Aduhelm (aducanumab) and as more become available, FDA may update labeling, she said.

FDA reviewers also said in briefing documents released Wednesday that the confirmatory trial that Eisai and Biogen ran to show their new Alzheimer’s drug has a clinical benefit did indeed have one, lining up for a likely full approval next month.

As far as why the committee meeting on Friday only included six voting members (one of whom was the patient representative), FDA’s Buracchio pointed to David Weisman’s recusal from the committee roster despite a conflict-of-interest waiver that noted he had been paid by both Eisai and Biogen as a trialist.

Buracchio confirmed that Weisman signed a letter written by the Alzheimer’s Association that was submitted to the docket for the meeting and offered support for the full approval of Leqembi and requested that CMS revisit its coverage policy was the reason for his and other recusals from the meeting.

“They said they no longer needed me,” Weisman told Endpoints in a phone interview earlier this week, noting the FDA was trying to diffuse any sort of potential conflict with his removal. Buracchio did not say who else was recused from the meeting due to the letter.

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