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
Untamed life Safe-havens All over the Planet Offering Remarkable Creature Experiences - 2As world leaders enter climate talks, people in poverty have the most at stake
- 3Wizz CEO: We’re going to invest $1 b. in Israeli market
- 4Deadly Switzerland ski resort fire was likely started by sparklers attached to champagne bottles, officials say
- 5Beneficial Growing Conditions in West Africa Weigh on Cocoa Prices
- German Easter peace marches draw tens of thousands
- Overlooked infertility care should be part of national health services, says WHO
- The Significance of Health Projects in Senior Protection.
- Gym tied to outbreak of obscure disease that spreads through mist
- A definitive Burger Confrontation: Which One Rules?
- Figure out How to Modify Your Pre-assembled Home for Greatest Solace and Stylish Allure
- Israel intensifies Lebanon attacks and hits areas not in Hezbollah's control
- Members of Kenya-led security mission in Haiti were involved in rapes, U.N. says
- The Golden Globes gift bag has nearly $1 million worth of swag for some winners and presenters. What's in it?
