Alzheimer’s drug gains FDA breakthrough status

Eli Lilly & Co rose after its experimental drug for Alzheimer’s disease gained breakthrough status from US regulators, a designation that will speed its consideration for approval.

Biogen Inc’s Aduhelm was approved for Alzheimer’s on June 7 after gaining breakthrough status in a controversial move by the Food and Drug Administration. Lecanemab, another drug being developed by Biogen and its partner Eisai Co, received the same designation Wednesday.

Lilly gained as much as 8.7% in trading before US markets opened, while Biogen fell 6.7%.

Like Aduhelm, Lilly’s donanemab attacks amyloid, an abnormal protein believed to be involved in the damage Alzheimer’s causes in the brain. Critics of the Biogen drug’s approval have said that human trials haven’t definitively shown its effectiveness, and that its $56,000 annual price tag is excessive.

Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year, according to a company statement Thursday. Analysts surveyed by Bloomberg currently estimate donanemab’s 2024 sales at $358 million.

Breakthrough therapy status is designed to speed development and review of drugs for serious or life threatening ailments. It doesn’t mean the FDA will approve the drug in question, or that the agency has determined that the experimental medicine represents a breakthrough.


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Alzheimer’s drug gains FDA breakthrough status