
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
Expert advice for new stargazers: How to begin your amateur astronomy journey15.11.2025 - 2
10 Hints for an Effective New employee screening25.09.2023 - 3
Step by step instructions to Guarantee the Strength and Life span of Your Pre-assembled Home19.10.2023 - 4
Abbott issues US device correction for some glucose monitors over faulty readings risk24.11.2025 - 5
Storm Goretti sweeps United Kingdom, France with winds over 120 mph09.01.2026
German finance minister sees advantages of smartphones in schools
Winona Ryder didn't take the 'Stranger Things' plot lightly. How 'otherworldly' grief and a kidnapping in her hometown informed her character.
Instructions to Expand Your Advantages from an Open Record Reward
From Overpowered to Coordinated: Individual Accounts of Cleaning up
Support Your Wellness: 20-Minute Home Exercises That Work
Which One Energizes You the Most These Tech Developments
How will the universe end?
It Looks Like a Tiny, Fluffy Dragon, But It's Really a Bird. Meet the Great Eared Nightjar
Manual for Tracking down One of a kind Store Inns













