The FDA established a Prescription Drug User Fee Act target date of Nov. 1 for the application, which was submitted through the agency's accelerated approval pathway. This designation compresses the review window to six months, down from the standard 10-month period reserved for treatments that offer significant clinical improvements for serious conditions.
In section Market Quotes
Agios Pharmaceuticals Stock Jumps on FDA Priority Review for Sickle Cell
Investors pushed Agios Pharmaceuticals shares up 13% to $42.29 on Tuesday, responding to the U.S. Food and Drug Administration granting priority review for the company's sickle cell disease treatment. The decision accelerates the regulatory timeline for mitapivat, potentially placing it on the market as a first-in-class oral therapy.
Should the agency approve the drug, mitapivat would become the first oral pyruvate kinase activator available for sickle cell patients. The application draws on findings from the Phase 2 and Phase 3 RISE UP trials, which focused on patients aged 16 and older. Mitapivat currently holds existing FDA approvals for the treatment of thalassemia and pyruvate kinase deficiency.
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