
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
Choosing Moving Styles for Your Restroom Redesign06.06.2024 - 2
‘Everybody Loves Raymond: 30th Anniversary Reunion’ premiere date: How to watch, channel, time, cast and more22.11.2025 - 3
Palestinians forced from West Bank refugee camps left in limbo as Israeli demolitions go on21.11.2025 - 4
Director of Swiss hospital describes the rush to treat the injured from Alpine resort bar fire02.01.2026 - 5
Robyn returns to music with 'Dopamine,' her 1st single in 7 years: 'Came to save music once again'12.11.2025
Practice environmental safety in Style: Divulging Famous Electric Vehicle Brands
Dominating the Remote Work Way of life: Individual Systems
It's been 20 years since MTV's golden couple split. These producers saw it all unravel.
Vote in favor of Your #1 Instructive Toy: Learning and Tomfoolery Joined
Dramatic Dominance d: A Survey of \Feelings in front of an audience\ Theater Play
6 Objections for an Ocean side Wedding
Why ordering takeout or calling the dog walker might lead to a happier relationship
The Fate of Rest: Patterns in Shrewd Beds
Find the Captivating Professional flowerbeds of the US












