Glafabra Granted Orphan Drug Designation
In March 2026 Glafabra was granted an Orphan Drug Designation by FDA.
Orphan Drug Designation (ODD) gives Glafabra a powerful competitive edge by granting 7 years of market exclusivity, Potentially millions in tax credits, waives hefty regulatory filing fees that total near $5 M, and opens doors to specialized government grants. It also smooths the way for a faster regulatory path with extra guidance from FDA, making the drug therapy easier to bring to market.
see this Press release to learn more. https://tinyurl.com/OrphanStatus
