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
5 Different ways Macintosh is Prepared to Overwhelm Gaming, Even Against Windows - 2December's overlooked meteor shower peaks next week — will the Ursids surprise us?
- 3Over 60 local leaders push Netanyahu to halt haredi draft bill, warn of social rift
- 4Greece eyes migrant repatriation centres outside the EU
- 5The Development of Shipping: Controlling Towards a More Associated Future
- Do-It-Yourself Home Style on a Careful spending plan: Imaginative Thoughts and Tasks
- The 10 Most Noteworthy Games in History
- Figure out How to Augment Eco-friendliness in Your Volvo XC40
- Expert advice for new stargazers: How to begin your amateur astronomy journey
- How will the universe end?
- Mother and Stepson Rescued After Being Swept Over 6 Miles in Paddleboarding Mishap
- Share your pick for the tree that you love for its novel magnificence!
- Vote In favor of Your Favored Kind Of Cheddar
- Baby takes 1st steps after receiving groundbreaking gene-edited therapy
