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
Conquering Social Generalizations: Individual Accounts of Strengthening25.09.2023 - 2Instructions to Expand Your Smash 1500's Presentation: Tips and Deceives19.10.2023
- 3Changing Negative Cash Mentalities: Enabling Your Monetary Excursion30.06.2023
- 4The Most Vital Crossroads in Olympic History07.07.2023
- 5Instructions to Arrange Your Compensation During Medical caretaker Prospective employee meetings17.10.2023
- 10 Demonstrated Systems to Develop Your Internet based Business
- An Extended time of Careful Nurturing: Individual Bits of knowledge on Bringing up Youngsters
- Understanding Various Sorts of Financial balances: An Extensive Outline
- Astronomers now say the moon is eating up molecules from Earth’s atmosphere
- From record warming to rusting rivers, 2025 Arctic Report Card shows a region transforming faster than expected
- Vote In favor of Your Favored Kind Of Vegetable
- Mystery foot suggests a second early human relative lived alongside Lucy
- Mossad unveils network of Hamas terror infrastructure across Europe
- The Golden Globes is happening Sunday: Who's nominated, who's hosting and how to watch
