Breaking News, Trials & Filings

Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Author Image

By: Charlie Sternberg

Associate Editor

A supplemental new drug application (sNDA) seeking approval of WELIREG (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL), has been accepted for priority review by the U.S. Food and Drug Administration (FDA). The sNDA is based on objective response rate (ORR) and duration of response (DOR) data from the Phase 2...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics