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
Agricultural drones are taking off globally, saving farmers time and money - 2Whale stranded off Germany for days is stuck again
- 3Hundreds rally in West Bank against Israeli death penalty for Palestinians
- 4Meet the astronauts about to make history on flight around the moon
- 5The Best Portable Applications for Emotional wellness and Prosperity
- When the moon hits your eye from your Orion ship up high, that's a 'mare'
- Scientists are getting our robotic explorers ready to help send humans to Mars
- Heart disease risk greater for women with a common condition they may not be aware they have
- How to watch the last supermoon of the year
- Coffee Prices Finish Higher on Brazil Cop Concerns
- Free Fuel Giveaway Sparks Traffic Mayhem Before Police Shut It Down
- Instructions to Keep an Inspirational perspective After Cellular breakdown in the lungs Treatment
- Independence from the rat race: How to Save and Contribute Shrewdly
- Jury says Johnson & Johnson owes $40 million to 2 cancer patients who used talcum powders
