May 11 (Reuters) – The U.S. Food and Drug Administration said on Monday it is seeking input on repurposing approved drugs for potential new uses across a range of diseases and conditions.
Here are more details:
• The regulator said it is seeking public input on identifying potential new uses for FDA approved drugs such as a new disease indication or a new patient population to speed up treatment availability by using existing knowledge about the drugs.
• The FDA is seeking information from patients, clinicians, researchers, and others on priority disease areas and potential candidates for drug repurposing, especially where data supports new uses but incentives to seek approval are limited.
• The agency is particularly interested in input on disease areas including metabolic diseases, neurodegenerative conditions, women’s and men’s health conditions, substance use disorders, and rare diseases.
• The FDA is requesting additional information on drug candidates with promising preliminary clinical data from case reports and findings from artificial intelligence that may warrant further study.
• “Too many patients lack effective treatment options, even when promising science exists,” said FDA Commissioner Marty Makary, adding that, “Drug repurposing can make better use of available scientific data to deliver effective treatment options for patients in need.”
• Input from the public will help inform how the FDA refines its approach to evaluating additional drug repurposing opportunities, including collaborations with the National Institutes of Health and the Centers for Medicare and Medicaid Services, it said.
(Reporting by Sneha S K in Bengaluru; Editing by Anil D’Silva)
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