
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
The 15 Best Business visionaries Under 4006.07.2023 - 2
6 Solid Vehicle Fix Administrations to Keep Your Vehicle in Prime Condition06.06.2024 - 3
Lego's $650 Pokémon set is already sold out as demand, preorders surge13.01.2026 - 4
Toilet rats? Washington health officials warn of possible rodents in sewer systems after floods20.12.2025 - 5
NASA chief Jared Isaacman says Texas may get a moonship, not space shuttle Discovery31.12.2025
‘More should be done’: UN pushes Syrian regime on justice for Druze, Alawites and minority groups
Hot Electric Vehicles for 2023
The 12 biggest space stories of 2025 — according to you
Sound Propensities: 20 Methods for helping Your Insusceptible Framework
Who plays Moana in the live-action remake? What to know about Catherine Lagaʻaia.
Defense Minister Katz moves to extend IDF service to 36 months
2 of Earth's rarest lightning phenomena captured simultaneously in once-in-a-lifetime photo
Figure out How to Store Your Gold Ventures: A Thorough Aide safely
Figure out How to Reveal Stowed away Open Record Rewards











