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
Pick Your Favored method of transportation - 2How much should a kid's birthday party cost? One mom spent $190 for pizza and ice cream at a park. Another paid $2K for a playspace and goodie bags.
- 3NASA Perseverance rover sees megaripples on Mars | Space photo of the day for Jan. 7, 2026.
- 4Instructions to Shield Your Gold Speculation from Possible Dangers: Fundamental Protections
- 5Figure out How to Remain Informed about the Most recent Open Record Extra Offers
- Audits of the Top Science fiction Movies This Year
- Health insurance premiums rose nearly 3x the rate of worker earnings over the past 25 years
- British Columbia's Secret Lakeside Town With Hot Springs Is 'An Oasis Of Arts, Culture And Relaxation'
- Are protests pushing Iran's Islamic regime toward a tipping point?
- Will Comet C/2025 R3 (PanSTARRS) be the 'great comet' of 2026?
- UAE-backed Yemeni Southern Transitional Council denies disbandment rumors
- Full Supreme Court to hear challenge to Judicial Selection Committee law
- Tech for Efficiency: Applications and Apparatuses to Accomplish More
- Far-right leader Le Pen to attend Brigitte Bardot's funeral
