FDA Sets July Decision Date for Full Approval of Leqembi

Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.

Pictured: FDA sign in front of building/courtesy Sarah Silbiger/Getty Images

The FDA has set a date of July 6, 2023 to decide on full approval of Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi (lecanemab).

The FDA will hold an advisory committee meeting regarding the application, for which it did not provide a date.

Leqembi won accelerated FDA approval in early January 2023. Studies of the antibody showed its ability to reduce the accumulation of amyloid beta plaque in the brain, a hallmark biomarker of AD.

Leqembi reduced clinical decline by 27% over placebo in patients with mild cognitive impairment or mild dementia.

In a Phase III trial, researchers measured the cognitive decline of 1,800 patients in areas of memory, orientation, problem-solving, community affairs, home/hobbies and personal care over 18 months.

Three additional studies of Leqembi are ongoing, Christopher Vancheri, associate director, corporate affairs and advocacy, Eisai told BioSpace in February.

AHEAD 3-45 focuses on preclinical AD patients with intermediate or elevated levels of amyloid in the brain. A study for dominantly inherited AD is also underway, in addition to a trial studying subcutaneous dosing of Leqembi.

Eisai submitted its supplemental Biologics License Application immediately following the accelerated nod. The granting of Priority Review status garnered the July 6th action date.

Full approval of the drug is vital for Medicare patients. The Centers for Medicare & Medicaid Services currently only cover anti-amyloid antibody drugs for patients enrolled in clinical trials. CMS made it clear Leqembi needs traditional FDA approval for broader coverage.

With a price tag of $26,500, patients need the win.

At this point, Leqembi is only approved for patients in mild stages of cognitive impairment or dementia, and many who would qualify medically may still be on private insurance. Private insurers often wait on a CMS decision to make their own coverage determinations.

While full FDA approval isn’t a guarantee for Medicare coverage, the medical community is hopeful.

“[Medicare coverage] would be a game changer for AD treatment...but that still remains to be determined,” Cindy Lemere, Ph.D., a scientist at Brigham & Women’s Hospital, told BioSpace in a previous interview.

While acknowledging that Leqembi is not a cure, Lemere said, “We are finally on a path to treat Alzheimer’s disease, and in the future, to prevent it.”

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.