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
Vote In favor of Your Favored Web-based Book Retailor - 2The most effective method to Integrate Compact disc Rates into Your Retirement Arranging
- 3Venus shines at its best in spring and summer 2026 — here's what to look for
- 4BravoCon 2025: How to watch, full schedule and lineup, where to stream free and more
- 5Dave Coulier reveals he has tongue cancer, his 2nd diagnosis in a year, after beating non-Hodgkin lymphoma
- African Forests Have Become a Source of Carbon Emissions
- Iran-backed Iraqi militias attack Kurdistan over 450 times since beginning of war
- Italian court approves extradition to Germany of Ukrainian suspect in Nord Stream pipeline blast
- Why won't NASA's Artemis 2 astronauts land on the moon when they get there?
- Italian police hold suspected boss of Naples Mafia's Mazzarella Clan
- Israel’s 'Stonehenge’ not alone with near 30 similar sites, satellite imagery reveals
- Grammy nominations 2026: Full list of nominees in every major category, including Album of the Year and Best New Artist
- Kuwait is softening stance on Israel, dissident tells ‘Post’ after viral UN speech
- The 3 little words TV fans can't stop obsessing over
