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
Want to be better about saving money in 2026? Try these money-saving tips for having a ‘low-buy’ January and beyond - 2Scaling New Levels: Rock Climbing Spots On the planet
- 3Remarkable Spots for Hot Air Swelling All over The Planet
- 4Is relief in sight? Flu season still brutal but cases are declining.
- 5The newest 'Project Hail Mary' trailer shows Ryan Gosling befriending an alien in Phil Lord and Chris Miller's space epic
- 5 VIPs That Changed Style
- Investigating the Medical advantages of Aloe Vera
- Rick Steves Recommends This German Town's Castle Hotel With Rhine River Views
- Iran begins cloud seeding to induce rain amid historic drought
- Europe's powerful Ariane 6 rocket launches Sentinel-1D Earth-observation satellite to orbit (video)
- How did I get my own unique set of fingerprints?
- ByHeart baby formula from all lots may be contaminated with botulism bacteria, tests show
- Releasing Learning Experiences: A Survey of the \Learning Made Fun\ Instructive Application
- Can scientists detect life without knowing what it looks like? Research using machine learning offers a new way
