
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
Pocket-Accommodating Jeep Wrangler Buying Guide for Seniors06.11.2023 - 2
She was the ultimate '90s fitness influencer. Now she's delivering Uber Eats — and rebuilding her life.04.12.2025 - 3
A company is trying to unlock a key to aging, in a long-overlooked body part31.12.2025 - 4
Lilly becomes first healthcare firm to join trillion-dollar club, Wall Street reacts21.11.2025 - 5
Beating Wellbeing Difficulties: Individual Victories in Health22.09.2023
New movies to watch this weekend: See 'We Bury the Dead' in theaters, rent 'Wicked: For Good,' stream 'The Unbreakable Boy' on Starz
ByHeart baby formula from all lots may be contaminated with botulism bacteria, tests show
Opening Innovativeness: Moving Thoughts and Tasks
Ancient fire discovery marks significant milestone in human history
In the stomach of a mummified wolf pup, scientists find DNA from a woolly rhinoceros
Figure out How to Track and Anticipate Future Cd Rates
Insane Realities That Will Make You Reconsider How you might interpret History
Gaza humanitarian efforts reach key milestone as UNICEF vaccinates some 13,000 children
Bayer reports positive results for blood thinner after 2023 setback













