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
5 Instructive Toy Brands for Youngsters - 2Pick Your Favored kind of books
- 3The Force of Systems administration: Individual Examples of overcoming adversity
- 4Climate change is straining Alaska's Arctic. A new mining road may push the region past the brink
- 52024 Eurovision winner Nemo returns trophy over Israel's participation
- Court clears Beersheba assault suspect of link to Haymanut Kasau disappearance, extends detention
- Here are 10 stores where you can get a free Thanksgiving turkey
- Weeks-Long Australian LNG Outage Will Further Tighten Supply
- The Drone Video of the Year is stunning – you've not seen Namibia like this
- Deadly attack on kindergarten reported in Sudan
- Munich Security Conference chief defends inviting AfD lawmakers
- Flu season is underway. What are common symptoms to watch for?
- How to get rid of your Christmas tree — and the 1 thing to never, ever do with it
- James Webb Space Telescope watches 'Jekyll and Hyde' galaxy shapeshift into a cosmic monster
