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
Artemis II astronauts race to set a new distance record from Earth and behold the moon's far side - 2Court clears Beersheba assault suspect of link to Haymanut Kasau disappearance, extends detention
- 3Birds at a college changed beak shapes during the pandemic. It might be a case of rapid evolution
- 4'Women on the floor, riddled with bullets': Ex-hostage Rom Braslavski recounts 'horrors' of Oct. 7
- 5German diesel hits new records over Easter weekend
- My Excursion to a Better Way of life: Health Experiences
- Newly discovered link between traumatic brain injury in children and epigenetic changes could help personalize treatment for recovering kids
- Fundamental Monetary Guidance for Going into Business
- The Iconic, Instantly Recognizable Plastic Chair That's Known All Around The World
- Polish law aimed at lowering petrol prices takes effect
- Bother Control Administrations for 2024: Decide for Your Home
- Figure out How to Augment the Advantages of a Web-based Degree
- 4 Must-Visit bar-b-que Eateries This Year
- Public Parks in the USA
