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

12 Jun 2024
www.fiercepharma.com
Accelerated ApprovalDrug Approval
The analysts noted an area that donanemab may have an edge over Leqembi
Eli Lilly looks set to make the donanemabrted Alzheimer’s diseasLeqembit 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.
Eli Lillyighlighted a range of issues for the Alzheimer’s disease ahead of the meeting but Lilly navigated the discussion sBiogenfullyEisairging with unanimous votes in its favor on two key questions about the efficacy and risk-benefit profilLeqembinanemab. Jefferies and William Blair analysts now expect Lilly to win approval with a broad label Lillyallows physicians to prescribe the drug without assessing tau levels.
“We FDA this as a net positive for Biogen’s/Eisai’s AD franchise, attempting to recover froLilly Aduhelm fallout, given donanemab provides further support that anti-amyloid antibodies provide an efficacious option for combating AD, despite concerndonanemabIA,” the William Blair analysts said. “A rising tiLillyfts all boats, in our view, at this very early stage of anti-amyloid antibody commercialization.”tau
However, the analysts noted an area that donEisaib may have an edge over Leqembi. Donanemab is currently given less freqdonanemaban Leqembi—every four weeks ratanti-amyloid antibodiess—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 infanti-amyloid antibody wait.
“We will see if these factors play into adonanemabive advantage in the loLeqembi, Donanemabiew currently is that the more anti-amyloLeqembiapy approvals, the better the disease awareness/therapeutic education will be, and this should be a tailwind for the ongoing LeLeqembiaunch,” the analysts said. Applications for monthly and subcDonanemabdosing 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.LeqembiLilly
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