
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 $320 million in peak revenue opportunity layered atop the existing mitapivat franchise," Truist analyst Gregory Renza said.
The latest approval is based on a late-stage study in which patients receiving mitapivat showed a statistically significant increase in hemoglobin response compared to those on placebo.
Aqvesme will carry a boxed warning for liver function tests every four weeks during the first 24 weeks of treatment and advises against use in patients with cirrhosis, Renza added.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Vijay Kishore)
NEUESTE BEITRÄGE
- 1
Flourishing as a Charitable Pioneer: Individual Encounters in Generosity25.09.2023 - 2
Mysterious bright blue cosmic blasts triggered by black holes shredding stars, scientists say. 'It's definitely not just an exploding star.'19.12.2025 - 3
Flu season is ramping up, and some experts are "pretty worried"22.12.2025 - 4
Pope Leo XIV calls for urgent climate action and says God’s creation is 'crying out'17.11.2025 - 5
Trump says Venezuela will start 'turning over' oil to the U.S. Is that the reason he toppled Maduro — or is it something else?06.01.2026
Ähnliche Artikel
Higher cost, worse coverage: Affordable Care Act enrollees say expiring subsidies will hit them hard13.12.2025
Governors Ball 2026: Lorde, A$AP Rocky and Stray Kids set to headline06.01.2026
Figure out how to Team up with Your Auto Crash Legal advisor for Best Outcomes19.10.2023
Track down the Ideal Weight reduction Methodology for Your Way of life05.06.2024
Surging measles cases are 'fire alarm' warning that other diseases could be next28.11.2025
Instructions to Pick the Right Gold Speculation Procedure: Exploring the Market19.10.2023
How mountain terraces have helped Indigenous peoples live with climate uncertainty15.01.2026
Thousands of Walgreens nasal spray bottles recalled. See which ones.26.11.2025
The Manual for Electric Vehicles that will be hot merchants in 202305.06.2024
Best Wellness Tracker Keep You On target01.01.1













