Eli Lilly & Co. plans to submit its Alzheimer’s drug for market clearance under an expedited review this year, in a sign that regulators are encouraging development of treatments for the disease after a recent approval.
Lilly said Thursday that the U.S. Food and Drug Administration had designated the company’s experimental Alzheimer’s drug, called donanemab, for the agency’s accelerated approval process.
The FDA decision comes after the agency cleared Biogen Inc.’s Aduhelm, the first Alzheimer’s therapy to receive approval in nearly two decades but one that has drawn criticism from doctors and researchers skeptical the drug works.
Lilly stock climbed more than 6% in morning trading. Many analysts predicted donanemab would be approved, perhaps by the middle of next year, and become a multibillion-dollar seller.
Shares in Biogen, meanwhile, dropped nearly 6% on concerns the company’s newly approved Alzheimer’s drug could face stiff competition sooner than expected. Both Aduhelm and donanemab target amyloid, a sticky substance in the brain associated with Alzheimer’s.