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
Concern for couple jailed in Tehran as British embassy closes - 2Hunger and makeshift shelters persist in north Caribbean nearly 2 months after Hurricane Melissa
- 3Hilary Duff releases 'Mature,' her 1st song in 10 years
- 4One of the best meteor showers of the year peaks at the worst possible time this week
- 5Iconic iceberg turns blue, on verge of totally disintegrating, NASA says
- Nations for Rock Climbing
- The most effective method to Connect Successfully with Teachers in a Web based Setting
- Malaysia To Revive Search for Missing Flight MH370
- The Force of Mentorship: Self-improvement through Direction
- This Week In Space podcast: Episode 188 — A New NASA Leader Rises?
- Figure out What Shift Differentials Mean for Your General Attendant Compensation
- Current Chateaus: Advancement and Style
- What to know about the hepatitis B shot — and why Trump officials are targeting it
- NASA to bring astronauts home from space station early due to a medical issue
