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
Governments take targeted action as fuel prices hit retail - 2Tremendous Spelunking: Cool Caverns All over the Planet
- 3Building a Flourishing Business: Illustrations from Business people
- 4A Manual for Pick High Evaluated Food Conveyance Administrations In Significant Urban communities For 2024
- 5Volkswagen Plant Could Pivot From Building Cars to Supporting Iron Dome Systems
- Explainer-What Novo Nordisk's weight-loss pill approval means for company, patients
- State asks High Court to reject challenge to anti-UNRWA laws ahead of Monday hearing
- Tablets: Upgrade Your Understanding Experience
- Instructions to Upgrade the Security Elements of Your Kona SUV
- How on earth did 'Shark Tank' star Kevin O'Leary end up in 'Marty Supreme'? I'll let him explain.
- Ukraine's new defense minister just outlined how dire its troop shortage has become
- Administrative building in Sharjah region targeted by Iranian drone, UAE authorities announce
- Al-Sharaa denies he called for 80% of Syrians to return from Germany
- 6 U.S. States for Climbing
