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FDA Orphan Disease Clinical Trial Grants Aim To Reduce Financial Risk

 
• By Brenda Sandburg
  
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Agency awards $22m to support 15 clinical trials and approximately $10m for six natural history studies in rare diseases. FDA Commissioner Gottlieb highlights the program as a way for the agency to help de-risk clinical development.

US dollars

FDA's latest round of funding of clinical trials for rare disease treatments will provide $22m over four years to 15 grant recipients. The studies include a Phase II trial of oxytocin, dubbed the "love hormone," for treatment of hyperphagia in Prader-Willi syndrome and a study of Novartis AG's leukemia drug Gleevec (imatinib) in combination with Array BioPharma Inc.'s binimetinib (MEK162) for the treatment of gastrointestinal stromal tumors.

FDA announced Oct. 6 that it is awarding the research grants through its Orphan Products Clinical Trials Grants Program, which...

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