FDA advisors will look at full Leqembi approval in June

FDA advisors will look at full Leqembi approval in June

The FDA has convened a meeting of an advisory committee in June to consider the bid by Eisai and Biogen to convert their accelerated approval of Alzheimer’s disease therapy Leqembi into a full approval – which could open the door to more widespread insurance coverage for the drug.

The meeting of the Peripheral and Central Nervous System Drugs Advisory Committee will be held on 9th June, according to a Federal Register notice, around a month before the FDA is due to deliver a verdict on the marketing application after a priority review.

Leqembi (lecanemab) was granted accelerated approval by the FDA in January, with a fairly broad label to treat Alzheimer’s disease patients in the mild cognitive impairment or mild dementia stage of disease, who have confirmed presence of amyloid pathology.

The prospects of the drug will depend on how the FDA and its advisors interpret the results of the CLARITY-AD trial, Eisai and Biogen’s confirmatory trial, which is essential to upgrade an accelerated approval to a full, traditional approval.

The study revealed a 27% improvement on placebo on its primary endpoint, the Clinical Dementia Rating scale (CRD-SB), in a readout published in the New England Journal of Medicine (NEJM) last November, but will continue to follow patients until 2027.

Sales of the $26,500 per year drug are expected to be very limited unless the FDA grants full approval, and the Centers for Medicare and Medicaid Services (CMS) relax restrictions on reimbursement of amyloid-targeting drugs introduced in the wake of the controversial approval and launch of Leqembi predecessor Aduhelm (aducanumab) last year.

At the moment, Leqembi is only reimbursable through Medicare for patients in clinical trials, although last month the US Department of Veterans Affairs became the first major insurer in the US to agree coverage of the drug, subject to certain conditions.

There is speculation that CMS could revisit its reimbursement decision if Leqembi gets full FDA approval on or before the FDA’s review deadline of 6th July.

Eisai said recently it was forecasting more than $7 billion in Leqembi sales by 2030 – assuming the CMS relaxes its stance on the drug and that it is also approved in other markets outside the US.

The pharma company is planning for approval of the drug in Japan in the middle of 2023, and in Europe and China before the end of the next fiscal year, ending 31st March 2024.

News of the adcomm meeting date emerged as Biogen kicked off a fresh round of staffing reductions, adding to almost 900 job losses last year that were precipitated by Aduhelm's failure to become a viable product.  The bulk of the latest round are in Biogen's multiple sclerosis team, hit by patent expiries and stiffer competition in the marketplace.