(Bloomberg) -- Eli Lilly & Co.’s drug for Alzheimer’s has benefits that outweigh its risks, US drug regulatory advisers said, bringing the treatment’s long path to the market closer to a successful end.  

Eleven advisers to the Food and Drug Administration voted unanimously on Monday that Lilly’s donanemab helps patients in the early stages of Alzheimer’s disease, and that those benefits outweight the drug’s risks. The FDA is expected to make a final decision on donanemab by the end of the year. 

Lilly shares rose 1.8% at the 4 p.m. close of trading in New York.

If approved, donanemab would compete against Leqembi, an Alzheimer’s medicine from Biogen Inc. and Eisai Co. that won US clearance last year. Each targets toxic clumps of a protein called amyloid, which is thought to drive the memory-destroying progression of Alzheimer’s. The intravenous drugs are the first to meaningfully alter the course of the disease in clinical trials, although Leqembi’s commercial uptake has lagged expectations.

Patients who receive amyloid-reducing therapy must first be tested for the presence of the brain protein. Lilly’s study excluded patients with no or low levels of another disease-linked protein, called tau, in their brains, which has raised questions about how widely its drug might be used. 

“I think the benefits outweigh the risks, and if there are some subgroups where further analysis is required it should not hold up to make this drug available to the public,” Costantino Iadecola, chair of Weill Cornell Medicine’s Feil Family Brain and Mind Research Institute and a panel member, said at the meeting. 

What Bloomberg Intelligence Says: 

Biogen and Eisai’s Leqembi and Eli Lilly’s donanemab are set to face off in the market for treatments that slow the course of Alzheimer’s disease, which our risk-adjusted analysis finds can surge to $13 billion by 2030 from $250 million this year. The next goal lies in presymptomatic intervention and incorporating blood-based biomarkers to identify at-risk individuals. 

Read the Deep Dive here. 

— BI analysts Jean Rivera Irizzary and Sam Fazeli. 

The FDA has been under fire for its approach to treatments for Alzheimer’s, in part because it still isn’t clear what role amyloid — the protein targeted by drugs like donanemab — plays in the disease. Some of the agency’s scientific advisers opposed the approval of Aduhelm, an earlier amyloid-lowering drug made by Biogen. Medicare, the government health program for the elderly, declined to pay for it. Biogen has since abandoned the drug. 

Leqembi, which has clearly shown that it slows patients’ mental decline, has full FDA approval, yet uptake has still languished. Donanemab’s path to market has been beset by delays, including an FDA rejection in 2023. The agency’s decision to convene Monday’s panel discussion was also unexpected and pushed back the drug’s expected timetable. 

The FDA also raised safety concerns with donanemab’s side effects — specifically instances of brain swelling and bleeding — during the panel meeting. The agency is considering a label that would include requiring patients to carry a medical identification card, Natalie Branagan, a clinical safety reviewer for the FDA, said. Other medications with similar side effects are being considered for labeling changes too, she said.

Donanemab, once considered integral to Lilly’s future, has been overshadowed by the company’s GLP-1 medicines for obesity, a market expected to surpass $130 billion a year by the end of the decade, according to analysts at Goldman Sachs. Still, sales of Alzheimer’s drugs are also expected to grow significantly. Bloomberg Intelligence analysts see them surging to $13 billion by 2030 from $250 million this year.  

(Updates with second vote from secondparagraph.)

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