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
6 Top Computer game Control center - 2If evolution is real, then why isn’t it happening now? An anthropologist explains that humans actually are still evolving
- 3Concern for couple jailed in Tehran as British embassy closes
- 4Ocean side Locations for a Family Excursion
- 5‘Slender Man’ attacker back in custody. What we know about Morgan Geyser's disappearance and what happens next.
- Revealing the Specialty of Food Matching: Improving Culinary Encounters
- Shipping: The Corridors of Trade and the Coming of Another Period
- The Most Compelling Innovation Developments Somewhat recently
- A definitive Manual for the Over-Ear Earphones
- Geminid meteors streak under green sky | Space photo of the day for Dec. 19, 2025
- As cases of a rare, deadly infection rise, doctors worry fewer teens will get vaccinated
- Everyday Seasonal Positions That Compensate Fairly in the US
- The year's first meteor shower and supermoon clash in January skies
- RFK Jr.’s vaccine advisers plan biggest change yet to childhood schedule
