Agios Pharma Gets Orphan Drug Status For Tebapivat To Treat Myelodysplastic Syndromes

(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO) Wednesday said the Food and Drug Administration or FDA has granted orphan drug designation to the company's drug candidate tebapivat for the treatment of myelodysplastic syndromes (MDS), a group of blood cancers.

A Phase 2a study of tebapivat in lower-risk MDS was completed last year. Agios is currently initiating a Phase 2b study of tebapivat in lower-risk MDS.

Orphan drug designation provides various benefits including tax credits, exemptions from certain FDA fees for clinical trials, and eligibility for seven years of market exclusivity after the drug is approved.