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FDA awards $18 million to fund trials of medical products for rare diseases
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The FDA awarded more than $18 million in grants over the next 4 years to fund clinical trials of medical products intended to treat patients with rare diseases.
“Developing a treatment for a rare disease can be especially challenging. Given the often small number of patients affected by certain very rare diseases, there can be limited markets for new treatments and — as a result — fewer resources devoted to researching these opportunities,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “The FDA is committed to doing its part to facilitate continued progress toward more treatments, and even potential cures, for patients with rare diseases.”
The FDA issued the grants through the Orphan Products Clinical Trials Grants Program. The program has provided more than $400 million to fund more than 600 clinical studies since 1983.
The grants are intended to fund studies that will evaluate the effectiveness and safety or products that could lead to or contribute to FDA approval of products intended to treat rare diseases.
“This funding helps support early-stage development activities targeting rare diseases that don’t have effective treatments,” Gottlieb said. “By providing seed capital, these FDA-administered grants enable researchers to prove out important concepts. The FDA grants also provide some important recognition to promising development programs that ultimately can help researchers attract additional funding.”
More than 100 rare disease experts reviewed grant applications for scientific and technical merit.