
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
Figure out How to Forestall Tooth Staining19.10.2023 - 2
Here's what can happen if you drive under the influence of pot26.11.2025 - 3
Yemen's Houthis ready to join Iran war if needed, raising new shipping risk27.03.2026 - 4
Magnetic fossils may reveal ancient creature's internal 'GPS system'17.11.2025 - 5
Spanish woman, 25, dies by legal euthanasia in case that drew national spotlight26.03.2026
Ähnliche Artikel
I spent the last year transforming my life. Becoming a Rockette for a day made me confront a fear I couldn't shake.10.12.2025
The risk of falling space junk hitting airplanes is on the rise, experts warn04.01.2026
Porsche May Kill the Electric Boxster Before It Ever Arrives01.04.2026
‘The White Lotus’ sparked online interest in risky anxiety pills, study says14.11.2025
I decided to become a single mother by choice. I wasn't ready to stop dating.16.12.2025
See the 'amazing' photos of Earth taken on historic Artemis II moon mission03.04.2026
The most effective method to Apply Antiquated Ways of thinking in Current Brain science Practices17.10.2023
Israel launches new wave of attacks against Hezbollah in Beirut27.03.2026
People who talk with their hands seem more clear and persuasive – new research04.12.2025
Instructions to Discuss Successfully with Your Auto Collision Lawyer19.10.2023














