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
Style Narratives: A Survey of \Patterns and Styles Assessed\ Design - 2Accomplishing Balance between fun and serious activities: Procedures for a Better Life
- 3Native artists in Texas and Mexico shared their vision of the universe for 4,000 years, ancient murals suggest
- 4Sea level doesn’t rise at the same rate everywhere – we mapped where Antarctica’s ice melt would have the biggest impact
- 5Santa's sleigh or the International Space Station? How to spot a bright Christmas flyby Dec. 24 and 25
- Munich Security Conference chief defends inviting AfD lawmakers
- RFK Jr. succeeds in changing hepatitis B recommendation | The Excerpt
- If evolution is real, then why isn’t it happening now? An anthropologist explains that humans actually are still evolving
- Zelensky sees new Russian attack threat from Belarus
- Is 'Stranger Things' releasing one last episode? The 'Conformity Gate' fan theory explained as speculation mounts.
- Which Brilliant Home Gadget Can't You Reside Without?
- Desired Travel Objections Worldwide: Where to Go Straightaway
- Instructions to Shield Your Gold Speculation from Possible Dangers: Fundamental Protections
- Steinmeier honours Italian 'guest workers' who rebuilt German economy
