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
Figure out how to Consolidate All encompassing Practices with a Degree in Brain research - 2Inn The executives: A Remunerating Profession Decision for Energetic People
- 3Intriguing Social Unesco World Legacy Locales All over The Planet
- 4EU chief urges Iran to free imprisoned protesters, lift internet ban
- 5Scientists detect X-ray glow from interstellar comet 3I/ATLAS extending 250,000 miles into space
- Father and son spending Christmas together after health scares
- Miss 'Stranger Things' already? Here's how you can get your Upside Down fix in 2026 with spinoffs, games and more
- IDF destroys two-kilometer-long Gaza terror tunnel in Beit Lahiya
- How to watch the ‘Wicked: One Wonderful Night’ special — now streaming
- Sound and Delightful: 12 Nutritious Smoothie Recipes
- Satellite data reveals a huge solar storm in 2024 shrank Earth's protective plasma shield
- Unusual 'ingredients' helped stars form in a galaxy near the Milky Way
- Palestinians reel under winter rains as Israel blocks Gaza shelter supplies
- From Squid Game to Your Party! Six Entertaining Test Games That Will Have You in Join
