Analysts tip Lilly’s Alzheimer’s launch to boost rival Leqembi

12 Jun 2024
www.fiercepharma.com
Accelerated ApprovalDrug Approval
Analysts tip Lilly’s Alzheimer’s launch to boost rival Leqembi
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Source: FiercePharma
The analysts noted an area that donanemab may have an edge over Leqembi
Eli Lilly looks set to make the long-deserted Alzheimer’s disease market a two-horse town—but that may be a good thing for Biogen and Eisai. William Blair analysts are tipping the anticipated approval of a rival anti-amyloid therapy to boost Leqembi by helping raise awareness, although they also see possible risks to the early frontrunner after Lilly waltzed through its advisory committee.
The FDA highlighted a range of issues for the experts to dig into ahead of the meeting but Lilly navigated the discussion successfully, emerging with unanimous votes in its favor on two key questions about the efficacy and risk-benefit profile of donanemab. Jefferies and William Blair analysts now expect Lilly to win approval with a broad label that allows physicians to prescribe the drug without assessing tau levels.
“We see this as a net positive for Biogen’s/Eisai’s AD franchise, attempting to recover from the Aduhelm fallout, given donanemab provides further support that anti-amyloid antibodies provide an efficacious option for combating AD, despite concerns with ARIA,” the William Blair analysts said. “A rising tide lifts all boats, in our view, at this very early stage of anti-amyloid antibody commercialization.”
However, the analysts noted an area that donanemab may have an edge over Leqembi. Donanemab is currently given less frequently than Leqembi—every four weeks rather than every two weeks—and takes less time to administer. Patients can spend up to four hours receiving Leqembi, an hour infusion followed by a three-hour waiting period. Donanemab requires a 30-minute infusion and a 30-minute wait.
“We will see if these factors play into a competitive advantage in the long term, but our view currently is that the more anti-amyloid therapy approvals, the better the disease awareness/therapeutic education will be, and this should be a tailwind for the ongoing Leqembi launch,” the analysts said. Applications for monthly and subcutaneous dosing of Leqembi could eliminate Lilly’s administration advantages.
The analysts added that they believe Leqembi’s “first-to-market status will continue to reap benefits past a donanemab approval date.” Exactly when donanemab could win approval is unclear, with its original PDUFA date being tossed out after the FDA called an advisory committee.
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