Home » FDA Grants Orphan Drug Designation to Prometic’s PBI-4050 for Alström Syndrome
FDA Grants Orphan Drug Designation to Prometic’s PBI-4050 for Alström Syndrome
Prometic has been granted orphan drug designation by the FDA for its orally active, anti-fibrotic, lead drug candidate, PBI-4050, for the treatment of Alstrӧm Syndrome.
The company is currently investigating the effects of PBI-4050 on multiple organs in an ongoing, open-label, Phase II clinical study in the UK. Prometic said an expansion of the clinical program is contingent on regulatory guidance from the FDA and EMA.
Upcoming Events
-
21Oct