
Dec 24 (Reuters) - Shares of Agios Pharmaceuticals (AGIO) jumped 18% on Wednesday after the U.S. Food and Drug Administration approved the expanded use of its drug for the treatment of a type of blood disorder.
The drug mitapivat is now approved as a treatment for patients with anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, the company said late on Tuesday.
Thalassemia is an inherited blood disorder affecting the body's ability to produce hemoglobin and healthy red blood cells.
The drug, under the brand name Aqvesme, is expected to be available in late January next year, following the implementation of the required safety program.
Mitapivat was already approved by the U.S. FDA in 2022 to treat low red blood cell counts in adults with pyruvate kinase deficiency, under the brand name of Pyrukynd.
"The approval unlocks an additional $320 million in peak revenue opportunity layered atop the existing mitapivat franchise," Truist analyst Gregory Renza said.
The latest approval is based on a late-stage study in which patients receiving mitapivat showed a statistically significant increase in hemoglobin response compared to those on placebo.
Aqvesme will carry a boxed warning for liver function tests every four weeks during the first 24 weeks of treatment and advises against use in patients with cirrhosis, Renza added.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Vijay Kishore)
LATEST POSTS
- 1
6 Agreeable Earphones To Wear06.06.2024 - 2
Bruno Mars tour 2026: How to get tickets for 'The Romantic Tour,' presale times, prices and more09.01.2026 - 3
European Travel Objections for 202405.06.2024 - 4
Vote In favor of Feasible Way You Prescribe to Shop for Garments01.01.1 - 5
All the ways Marjorie Taylor Greene has shifted her approach lately — and why Trump is 'surprised at her'13.11.2025
21 Incredibly Entertaining Contemplations To Observe Consistently
Seven deaths possibly linked to malfunctioning glucose monitors
Hoist Your Style: Famous Hairdos for Ladies
Kendall Jenner addresses long-standing rumor about her sexuality
'A completely new manufacturing frontier': Space Forge fires up 1st commercial semiconductor factory in space
Instructions to Upgrade the Security Elements of Your Kona SUV
Pick Your #1 Japanese Food
A Manual for Nations with Extraordinary Food
America's Confided in Cooler in 2024











