The US Food and Drug Administration (FDA) has awarded 21 new clinical trial research grants through the Orphan Products Clinical Trials Grants Programme to boost the development of products for patients with rare diseases.
The new grants, totalling more than $23 million for the next four years, were awarded to principal investigators from academia as well as industry with research spanning domestic and international clinical sites.
Go deeper with GlobalData
FDA office of orphan product development, within the office of special medical programmes director Gayatri Rao said: “We are proud of our 30-year track record of fostering and encouraging the development of safe and effective therapies for rare diseases through our clinical trials grant programme.
“The grants awarded this year will support much-needed research in 21 different rare diseases, many of which have little, or no, available treatment options.”
Aimed at encouraging clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases, the grants are intended for clinical studies that assess the safety of products.
The Orphan Products Clinical Trials Grants Programme was created in 1983 and has provided more than $370 million since then to fund more than 590 new clinical studies.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataFive of the studies funded by this programme supported product approvals last year alone, including treatments for neuroblastoma, lymphangioleiomyomatosis, hypoparathyroidism, and hypophosphatasia.
About 24% of the new grant awards fund studies enrolling patients with cancer, 40% target devastating forms of brain cancer, while 43% fund studies that enrol paediatric patients as young as newborns.
Two of these studies focus on research in transplantation and related issues.
One funded project is a medical device trial to develop a fully implantable neuroprosthesis for the grasp, reach and trunk function in individuals with spinal cord injury.
