A new Alzheimer’s drug developed by Eisai and Biogen took a major step toward full approval, after a U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously to confirm its efficacy and clinical benefit.

Back in January, lecanemab – which will sell under the brand name Leqembi – was approved by the FDA under its Accelerated Approval pathway. The June 8, 6-0 vote by the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) puts the drug on track for full, traditional approval.

The committee cited data from Nutley-based Eisai’s Phase 3 Clarity AD clinical trial, which confirmed the clinical benefit of Leqembi. Additionally, committee members confirmed the overall-benefit risk profile of the drug, the clinical meaningfulness of the data, and discussed its use in specific subgroups.

The medicine will be used to help early-stage patients with mild cognitive impairment or the mild dementia stage of the debilitating neurodegenerative disease that affects more than 6.5 million Americans. Lequembi, a monoclonal antibody, is among a new category of Alzheimer’s medications that targets the root of the disease by reducing sticky clumps of toxic proteins in the brains.

The Phase 3 trial showed that the drug slowed the rate of cognitive decline by 27% over an 18-month study involving participants experiencing the early stage of Alzheimer’s.

“The Alzheimer’s Association welcomes and celebrates this action by the FDA Advisory Committee to support traditional approval of Leqembi for people with early Alzheimer’s,” said Joanne Pike, Alzheimer’s Association president and CEO. “With this action we are one step closer to more people living with Alzheimer’s having more time with more of their capabilities in tact – to do the things they want to do and love to do best.”

This endorsement from the advisory committee sets the stage toward full traditional FDA approval by July 6, 2023, as the agency now conducts its review.

‘Now all eyes turn to CMS’

In addition to the full FDA clearance, next steps will also include working with public and private health insurance entities to ensure access to the drug, which costs roughly $26,500 per year. But, there have been some positive developments on that front, especially if Leqembi receives full FDA approval.

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare would cover this new class of developing Alzheimer’s drugs, such as Leqembi, if they receive traditional FDA approval and if clinicians register and enter data in a registry.

“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” said CMS Administrator Chiquita Brooks-LaSure. “If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I’m pleased to make this announcement as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon.”

The Alzheimer’s Association said that while this is an important signal that CMS wants to improve access to FDA-approved treatments, they believe that registry conditions are an unnecessary and potential harmful barrier. The group added that while approval of Leqembi appears to be just weeks away, CMS has not shared details relevant to ensuring patients and physicians can enroll with as few barriers as possible.

“We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks,” said Pike. “Now all eyes turn to CMS. Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval. Americans living with Alzheimer’s disease deserve access to FDA-approved therapies without barriers, just like people with cancer, heart disease and HIV/AIDS.”

Still, as the scenario plays out over the next few weeks and months, it is all a step in the right direction for those suffering through the debilitating effects of Alzheimer’s disease.

“While the thought of a cure for Alzheimer’s disease is certainly part of my optimism, I’d like you to know that for me, more time is enough for now,” Myra Garcia, member of the Alzheimer’s Association Early-Stage Advisory Group, told the committee Friday. “And that is the promise of treatments like lecanemab.”