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
Air New Zealand cuts flights and hikes fares as fuel prices surge - 2Stolen Renoir, Cézanne and Matisse were probably uninsured, market sources say
- 3Moon memorial: Artemis 2 astronauts name lunar 'bright spot' after mission commander's late wife
- 4Rick Steves' Favorite Time To Visit Spain Has Lower Prices And Fewer Crowds
- 5South African army arrive in crime hotspots to help tackle gangs
- Step by step instructions to Get the Best Vehicle Rent Arrangement: Insider Tips and Systems
- UAE recalls some Nestle infant formula products, Qatar warns consumers
- Attacks on Iran's Bushehr nuclear plant and on Iraq border crossing
- Bolsonaro briefly leaves Brazilian prison for medical tests after a fall from his bed
- Improving as a Cook: Culinary Experiences in the Kitchen
- Vote in favor of the bloom plan that adds a bit of excellence to your life!
- Agricultural drones are taking off globally, saving farmers time and money
- Cocoa Prices Settle Lower on Expectations of Adequate Supplies
- Instructions to Expand Your Smash 1500's Presentation: Tips and Deceives
