
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
Bomb blast in packed Nigerian mosque kills five24.12.2025 - 2
At least 36 dead in major fire in Hong Kong residential blocks26.11.2025 - 3
Sean 'Diddy' Combs faces new sexual assault allegations, currently under investigation by Los Angeles Sheriff's Department18.11.2025 - 4
What you need to know about flu treatments as cases spike across the US31.12.2025 - 5
Figure out How to Stay away from Normal Handshaking Missteps19.10.2023
The Minimized Passage Horse: Reconsidering a Symbol for the Cutting edge Period
Giant ‘toothed’ birds flew over Antarctica 40 million to 50 million years ago
Which Diet Prompts the Incomparable Wellbeing Results?
Top Breakfast Food: What's Your Morning Enjoyment?
the 6 Shrewd Beds for seniors: A Complete Survey
Fundamental Home Items Each Animal person Needs
Grasping the Elements of Medical caretaker Pay rates: Factors That Shape Your Pay
10 times the sky amazed us in 2025
Instructions to Utilize Your Brain science Certification to Work on Corporate Culture












