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 Home EV Chargers for Proficient and Solid Charging - 2Washington state experiences historic flooding as Skagit River hits record high level. See flooding maps, highway closures and forecasts.
- 3Israel's haredi draft crisis: Court ruling and political stalemate reach breaking point
- 4How did life begin on Earth? New experiments support 'RNA world' hypothesis
- 5Poland identifies two Ukrainian suspects in railway sabotage blast
- Most loved Public Dish: Which One Addresses Its Nation Best?
- Skeleton of famed musketeer possibly found in Dutch church
- Sources: IDF does not actually know how many ballistic missiles Iran has left
- Vehicle Lovers' Decision: Purchase A Reasonable Vehicle
- Make your choice for the music application with the most amicable connection point!
- The Fate of Gaming: 5 Energizing Advancements Not too far off
- Step by step instructions to Figure out the Natural Effect of 5G Pinnacles
- The Most Moving TED Talks You Want to Watch
- James Webb Space Telescope watches 'Jekyll and Hyde' galaxy shapeshift into a cosmic monster
