
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
Find the Advantages of Innovative Leisure activities: Supporting Creative mind and Self-Articulation - 2
Experience Arranging: Planning for Epic Excursions - 3
The many ways that baking is winter therapy. With a delicious ending - 4
7 Well known Vacation spots In The US - 5
Best Amusement Park in Asia: Which One Is a Must-Visit
Figure out how to Amplify Your Open Record Reward
2026 Golden Globes: How to watch, start time, TV channel, full nominee list and more
The German series proving subtitles can be sexy — and wildly addictive
2 new malaria treatments announced as drug resistance grows
Figure out How to Use Your Nursing Abilities for Better Compensation
NASA to bring astronauts home from space station early due to a medical issue
Audits of the Top Science fiction Movies This Year
Genesis Marks 10th Anniversary With Magma GT Concept Aimed at High-Performance Flagships
Astronomers discover never-before-seen celestial object: "Cloud 9"













