Eli Lilly & Co rose after its experimental drug for Alzheimer\u2019s disease gained breakthrough status from US regulators, a designation that will speed its consideration for approval.<\/p>\n
Biogen Inc\u2019s Aduhelm was approved for Alzheimer\u2019s 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.<\/p>\n
Lilly gained as much as 8.7% in trading before US markets opened, while Biogen fell 6.7%.<\/p>\n
Like Aduhelm, Lilly\u2019s donanemab attacks amyloid, an abnormal protein believed to be involved in the damage Alzheimer\u2019s causes in the brain. Critics of the Biogen drug\u2019s approval have said that human trials haven\u2019t definitively shown its effectiveness, and that its $56,000 annual price tag is excessive.<\/p>\n
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\u2019s 2024 sales at $358 million.<\/p>\n
Breakthrough therapy status is designed to speed development and review of drugs for serious or life threatening ailments. It doesn\u2019t mean the FDA will approve the drug in question, or that the agency has determined that the experimental medicine represents a breakthrough.<\/p>\n