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
The Manual for Decent European Urban communities in 2024 - 22 of Earth's rarest lightning phenomena captured simultaneously in once-in-a-lifetime photo
- 3SpaceX launches Starlink missions in dual-coast spaceflight doubleheader (videos)
- 4Flu season is ramping up, and some experts are "pretty worried"
- 5Instructions to Utilize Your Brain science Certification to Work on Corporate Culture
- Instructions to Decide whether a Fender bender Legal counselor is Required for Your Particular Case
- Christopher Nolan's 'The Odyssey' trailer: See Anne Hathaway, Matt Damon and Tom Holland in 1st look at movie
- The Excursion to Monetary Proficiency: Individual budget Triumphs
- Toyota Motor Europe to roll out smart EV charging through new partnerships
- Figure out How to Amplify the Resale Worth of Your Kona SUV
- Living Abroad: Social Inundation and Self-improvement
- Miley Cyrus flashes a diamond ring on the red carpet, sparking engagement rumors with Maxx Morando: A timeline of their four-year relationship
- Russia accidentally destroys its only way of sending astronauts to space
- Help Your Insusceptibility: Good dieting and Way of life Tips
