The U.S. Food and Drug Administration (FDA) awarded $15 million in grants to fund 12 new clinical trials over the next four years to foster the development of rare disease treatments.
The grants were awarded through the FDA’s Orphan Products Clinical Trials Grants Program that was provided by Congress to specifically encourage the development of treatments for rare diseases. The grants are intended to substantially contribute to the marketing approval of products to treat rare diseases or provide essential data needed for the development of such products. The FDA selected the 12 recipients out of 89 different applications that were evaluated by more than 100 rare disease experts, the agency said.
FDA Principal Deputy Commissioner Amy Abernethy said the regulatory agency has provided “much-needed financial support” to clinical trials for rare disease treatments for more than three decades. Over that time, the more than $400 million provided by these grants has led to the approval of more than 60 different drugs for rare diseases, she said.
“We are encouraged by the amount of interest we continue to have in the grants program and are committed to working with researchers and industry to facilitate and support the study and development of treatments for patients with rare diseases,” Abernathy said in a statement.
