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
Vial marked 'Polonium 210' sparks scare during German Easter egg hunt - 26 Natural products High In Vitamins,Which One Do You Like to Eat
- 3Find the Abilities Required for Advanced Advertising Position
- 4Europe picks companies to help build Argonaut moon lander
- 5'We were genuinely astonished': This moss survived 9 months outside the International Space Station and could still grow on Earth
- A somber Thor is returning for 'Avengers: Doomsday': Watch the dread-filled teaser
- Choosing Moving Styles for Your Restroom Redesign
- Vote In favor of Your Favored Language Learning Applications
- Charlotte faith leaders hold interfaith forum on Black and Palestinian solidarity
- Guaranteeing Quality Medical care with Federal medical care Benefit Plans.
- War in Iran could exacerbate German housing crisis, minister warns
- CDC's upcoming vote on hepatitis B vaccine could impact childhood immunization
- EU chief urges Iran to free imprisoned protesters, lift internet ban
- Virtual National Science Foundation internships aren’t just a pandemic stopgap – they can open up opportunities for more STEM students
