The Food and Drug Administration wants to gather input from outside experts to better understand the safety and effectiveness of donanemab, according to a statement from Lilly on Friday. This unexpected decision comes just before the anticipated approval decision by the FDA. The date for the advisory panel meeting has not been set yet.
The delay is another setback for Lilly’s drug, which targets a toxic protein in Alzheimer’s patients’ brains and has shown benefits in slowing cognitive decline in trials. However, there have been side effects observed in studies such as brain swelling and bleeding, requiring careful monitoring to detect these issues early.
Following this news, Lilly’s shares dropped by 1.6% in New York trading. The FDA refrained from commenting due to regulations concerning drug applications and approvals.
Experts and doctors specializing in Alzheimer’s disease at a medical conference in Lisbon expressed disappointment and surprise at the FDA’s decision, as reported by an attendee. They were optimistic about the drug receiving approval soon.
In an interview, Donna Wilcock, director of the Center for Neurodegenerative Disorders at Indiana University School of Medicine, shared her disappointment with the decision. She speculated that the discussion during the panel might focus on the need for repeat brain scans in patients.
If approved, the FDA label for donanemab could include information on when to stop the drug and other prescribing recommendations for physicians based on Lilly’s trial approach.
This unexpected move by the FDA to convene a panel could suggest increased caution in reviewing complex drug applications, following backlash over the approval of Biogen Inc.’s Aduhelm. Aduhelm faced criticism despite accelerated approval and saw limited commercial success.
The planned hearing is likely to delay the final decision on donanemab by a few months. Lilly executives expressed surprise at the timing of the decision and stated their confidence in the drug’s benefits for patients.
If approved, Lilly’s donanemab will compete with Eisai Co.’s Leqembi, which received full FDA approval. Leqembi is the first drug proven to slow the progression of Alzheimer’s disease in a large trial.
This new development increases the likelihood of a more complex label for Lilly’s drug compared to Leqembi, according to an analyst at RBC Capital Markets.
Lilly executives had initially applied for accelerated approval based on mid-stage results but were asked to submit data from a final-stage trial, leading to the current review process.
Before the latest delay, Lilly had indicated that a decision would be made by the end of the first quarter. The unexpected hearing has caused a ripple in the timeline for approving donanemab.
Overall, the decision to convene an advisory panel at this stage is considered unexpected and unusual by Lilly executives, who remain optimistic about the drug’s potential.
(Updates with FDA response in fourth paragraph, expert comments in sixth)
Contact reporters on this story:
Robert Langreth in New York at rlangreth@bloomberg.net;
Madison Muller in New York at mmuller84@bloomberg.net
Contact editors for this story:
Peter Vercoe, John Lauerman
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