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Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab (Revised)

The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States to reduce the cognitive decline associated with early Alzheimer’s disease.

On Jun 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 11-0, unanimously recommending the approval of Eli Lilly’s LLY Alzheimer's disease drug, donanemab.

The committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and a clinically meaningful slowdown in disease progression for early symptomatic Alzheimer’s patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns. Lilly is seeking approval for donanemab for the treatment of patients with mild Alzheimer’s disease.

Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Both Leqembi and donanemab are Aβ targeting therapies. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease. However, anti-amyloid antibodies can cause a brain swelling side effect called amyloid-related imaging abnormalities (ARIA). In clinical studies, ARIA-E (ARIA - edema/effusions) was observed in 24% and ARIA-H (ARIA-hemorrhage/hemosiderin deposition) in 31% of donanemab-treated patients. However, to Lilly’s advantage, the panel said such risks could be addressed by “appropriate labeling and management.”


Most analysts are now expecting donanemab to gain FDA approval with a broad label and a warning for ARIA. Leqembi’s label also has a similar warning for ARIA. A PDUFA date, however, has not been scheduled by the FDA for a decision on donanemab after the original decision was delayed for the need of the advisory meeting.

Until Leqembi was approved, the drugs available in the market just treated the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease despite making significant investments. Biogen/Eisai’s controversial medicine, Aduhelm, was approved by the FDA in 2021. However, in January 2024, Biogen discontinued the development and commercialization of Aduhelm as the drug failed to generate any significant sales due to a lack of access to Medicare beneficiaries.

However, with donanemab just one step away from approval, the Alzheimer’s market could soon get two drugs. Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.

Biogen/Eisai are also quite bullish on Leqembi’s progress. Though Leqembi has had a lackluster launch, Biogen and Eisai expect the sales of Leqembi to grow in 2024, with signs of acceleration seen in the first quarter. Biogen and Eisai believe it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease.

The Centers for Medicare & Medicaid Services has also granted broad reimbursement to Leqembi under Medicare plans. Leqembi is also approved in China and Japan, which could bring in additional sales going forward. Regulatory applications seeking the approval of Leqembi are under review in Europe.

Prothena Corporation PRTA, AC Immune and Cassava Sciences SAVA are also developing therapies for Alzheimer's disease. Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.

Cassava Sciences is conducting a phase III program consisting of two global studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Top-line data from the 52-week RETHINK-ALZ study is expected by the end of 2024, while that from the second study, the 76-week REFOCUS-ALZ study, is expected by mid-year 2025.

Though there are some challenges and administrative hurdles associated with the marketing of Alzheimer’s drugs, the entry of additional players should further raise disease awareness and benefit the Alzheimer’s market as a whole.

Lilly and Biogen carry a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

(We are reissuing this article to correct a mistake. The original article, issued on June 12, 2024, should no longer be relied upon.)

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