FDA poised to decide on traditional approval of Leqembi in July

Therapy is second amyloid-targeting treatment to win accelerated approval

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has agreed to review a request to convert Leqembi’s (lecanemab) accelerated approval to a traditional approval for treating Alzheimer’s disease.

The FDA has granted priority review to the supplemental biologics license application (sBLA) and the agency is expected to make a decision by July 6, according to a press release from Eisai.

According to Eisai, which developed the therapy with Biogen, the FDA plans an advisory committee meeting so experts can review the available data on Leqembi. The date for that meeting hasn’t been set.

A feature of Alzheimer’s disease is the formation in the brain of toxic aggregates (clumps) of a protein called amyloid-beta. Leqembi is designed to help clear these clumps, which are thought to drive the disease’s progression.

The FDA granted Leqembi accelerated approval earlier this year. An accelerated approval gives companies conditional permission to start marketing a therapy based on early clinical evidence that it’s likely to be effective. Developers are still required to do additional clinical testing to confirm that.

Leqembi is the second amyloid-targeting therapy to win accelerated approval by the FDA. Biogen’s anti-amyloid medicine Aduhelm (aducanumab) received accelerated approval in 2021, a move that proved controversial.

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The FDA recently rejected a request for accelerated approval from Eli Lilly for its amyloid-targeting therapy donanemab, citing a lack of long-term clinical trial data.

Leqembi’s accelerated approval was supported by data from a Phase 2 trial called Study 201 (NCT01767311), which tested it against a placebo in more than 800 people with early Alzheimer’s. Data from the trial showed twice-monthly infusions reduced amyloid-beta aggregation as designed and slowed cognitive decline.

Eisai’s application for a traditional pathway approval is being supported by data from the Phase 3 CLARITY AD trial (NCT03887455), which enrolled 1,795 people with early Alzheimer’s who were randomly assigned to receive Leqembi or a placebo for 18 months.

The study’s main goal was to assess the rate of cognitive decline, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Results showed after 18 months, the rate of decline in the CDR-SB was significantly slower — by about 27% — with Leqembi compared with a placebo.

The FDA said that findings from CLARITY AD can be used to support the therapy’s full approval, according to Eisai.

Other measures of cognitive function and patients’ ability to participate in daily activities also favored Leqembi over a placebo, in general. Imaging data indicated Leqembi led to fewer amyloid plaques.

The most common side effects reported were infusion-related reactions, which affected about one in four patients. A form of brain swelling associated with anti-amyloid therapies, called ARIA, was reported in just over one in 10 patients.