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
Exploring the School Application Cycle: Understudy Bits of knowledge - 2Benedict Cumberbatch takes on something even Sherlock can’t solve: male grief
- 3A rare whale is having an encouraging season for births. Scientists warn it might still go extinct
- 4How 2025 became the year of comet: The rise of interstellar 3I/ATLAS, an icy Lemmon and a cosmic SWAN
- 5How a Snake That Eats Cobras Redefined the Meaning of ‘King’
- What happened in 'Wicked' part 1 and will there be a 3rd movie? Recap and what Ariana Grande, Jon M. Chu have said about a sequel.
- Yasser Abu Shabab's killing raises questions about Israel's militia strategy in Gaza
- Step by step instructions to Explore the Close to home Consequence of Cellular breakdown in the lungs
- Unraveling the Specialty of Picking Your Ideal Travel Objective
- Watch China's Shenzhou 22 rescue ship arrive at Tiangong space station (video)
- Miley Cyrus details her fear of paper, says fiancé Maxx Morando opens their packages outside: 'That's really why I got engaged'
- Police break up illegal chicken slaughter in Germany
- Proficient Cultivating Devices for a Lovely and Useful Nursery in 2024
- The Following Huge Thing: 5 Progressive Tech New businesses
