FDA could fully approve Alzheimer’s drug from partners Eisai & Biogen by July 6

RESEARCH TRIANGLE PARK – Japan-based pharma Eisai and its US partner Biogen, which has a large campus in RTP, could receive full FDA approval for their Alzheimer’s drug by July 6, the companies announced Monday.

The drug, Leqembi, received preliminary approval in January. It’s for patients with mild or early cases of dementia tied to Alzheimer’s disease.

To date, however, sales have been minimal.

• MORE COVERAGE: Read the full announcement from Biogen and Eisai.

Two big factors behind the slow debut, experts say, are scant insurance coverage and a long setup time needed by many health systems.

Patients who surmount those challenges will step to the head of the line for a drug that delivers an uncertain benefit.

Regulators used the FDA’s accelerated pathway, which allows drugs to launch before they’re confirmed to benefit patients. In studies, Leqembi modestly slowed the fatal disease, but doctors aren’t sure yet how that translates into things like greater independence for patients.

Patients get the drug by IV every two weeks. Eisai says the company has shipped Leqembi to U.S. specialty drug distribution centers. From there, it can be delivered overnight to hospitals or medical centers.

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A year’s treatment will run about $26,500. Patients who can afford that without insurance will be able to start the treatment if they are deemed a candidate for Leqembi and they find a doctor and health care system prepared to help them.

There are currently few options outside self-pay. Most of the patients who may be candidates for this drug are on Medicare, and the federal program’s coverage is narrow so far. It has said it will cover treatments like Leqembi only for patients enrolled in certain research trials designed to test the drug.

There are no such studies currently accepting new patients.

Eisai estimates that about 100,000 people will be diagnosed and eligible to receive Leqembi in the United States by 2026. Representatives of the drugmaker declined to estimate how many people might receive it this year.

Biogen’s expensive Alzheimer’s drug OK process was ‘rife with irregularities,’ congressional probe finds

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