{"id":611362,"date":"2024-06-11T12:22:00","date_gmt":"2024-06-11T16:22:00","guid":{"rendered":"https:\/\/platohealth.ai\/donanemab-approval-would-fuel-growth-of-amyloid-blocking-alzheimers-drugs-analysts-say\/"},"modified":"2024-06-11T18:16:30","modified_gmt":"2024-06-11T22:16:30","slug":"donanemab-approval-would-fuel-growth-of-amyloid-blocking-alzheimers-drugs-analysts-say","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/donanemab-approval-would-fuel-growth-of-amyloid-blocking-alzheimers-drugs-analysts-say\/","title":{"rendered":"Donanemab approval would fuel growth of amyloid-blocking Alzheimer\u2019s drugs, analysts say","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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Approval of Eli Lilly\u2019s experimental Alzheimer\u2019s disease drug donanemab would help drive sales of Eisai and Biogen\u2019s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab.<\/p>\n

\u201cA rising tide lifts all boats, in our view,\u201d wrote Myles Minter, an analyst at William Blair, in a client note. Donanemab works similarly to Leqembi by eliminating from the brain a toxic protein called amyloid that scientists see as linked to Alzheimer\u2019s progression.<\/p>\n

Leqembi\u2019s adoption since its U.S. approval last year has been slow, however. While more than one million people are estimated to be eligible for amyloid-blocking drugs, Leqembi recorded only $19 million in sales over the first quarter.<\/p>\n

There’s ongoing debate around which drug, Leqembi or donanemab, would hold an advantage on the market. The former seems slightly safer, while the latter has more convenient dosing.<\/p>\n

Leqembi\u2019s \u201cclear safety advantage is a huge deal for risk-averse neurologists,\u201d Stifel analyst Paul Matteis wrote in a note to clients ahead of Monday\u2019s FDA meeting. At that meeting, expert FDA advisers voted 11-0 that donanemab\u2019s benefits outweigh its risks, positioning the drug to likely secure an approval from the agency soon.<\/p>\n

But some analysts also argue the two products could, paradoxically, help each other. Lilly using its “marketing muscle to educate and further establish delivery infrastructure should benefit” Biogen and Leqembi, according to Brian Abrahams of RBC Capital Markets.<\/p>\n

Leqembi and donanemab are the products of decades of work and billions of dollars of research investment into the hypothesis that blocking or removing amyloid deposits can slow the cognitive and functional decline caused by Alzheimer\u2019s. That track record includes the high-profile failures of four major amyloid-blocking drugs, as well as the launch, controversy and subsequent withdrawal of Biogen\u2019s Aduhelm.<\/p>\n

Leqembi\u2019s arrival was seen as a development that would usher in widespread use, but Eisai and Biogen have faced resistance from insurers. Most notably, the Medicare program for the elderly didn\u2019t authorize coverage until the FDA converted its initial conditional authorization for the drug into a full standard approval.<\/p>\n

An approval of donanemab could \u201caccelerate the uptake of this class by helping build the commercial infrastructure\u201d the drugs require, Leerink Partners analyst Marc Goodman wrote in a Monday note.<\/p>\n

Having two available medicines will also raise awareness among physicians and patients, which should help build demand, according to Jefferies analyst Michael Yee.<\/p>\n

Which drug is preferred will depend on how doctors, patients and insurers balance the risk of adverse events \u2014 primarily a type of brain swelling called ARIA that\u2019s linked to the removal of amyloid from brain tissue \u2014 against the dosing advantage of donanemab.<\/p>\n

Donanemab requires infusions once every four weeks versus Leqembi\u2019s once every two weeks, and was effective enough in removing amyloid that people could stop taking it on average after 47 weeks in Lilly\u2019s main clinical trial.<\/p>\n

The increased ARIA risk will likely require more frequent magnetic resonance imaging tests for donanemab patients to detect signs of the side effect, increasing costs and treatment burden for patients.<\/p>\n

On the other hand, donanemab\u2019s less frequent and limited-time dosing could work in the opposite direction. The Institute for Clinical and Economic Review, an influential nonprofit, had estimated in a draft review<\/a> that donanemab would cost less than Leqembi on a per life year gained basis if both drugs were priced at parity. (The organization later withdrew that evaluation after the FDA turned back an earlier Lilly application for approval.)<\/p>\n

Donanemab \u201cwill elevate and help build\u201d the market for amyloid-blocking drugs, according to Stifel analyst Matteis. But he doesn\u2019t think the two drugs will take market share from each other. \u201cWe think much lower ARIA and less frequent dosing balance out, with place for both,\u201d Matteis wrote.<\/p>\n

Jacob Bell contributed writing.<\/em><\/p>\n