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
Instructions to Explore the Universe of Vehicle Leases - 2How much would you pay to meet a Real Housewife? At BravoCon, the limit does not exist.
- 3Etymological Investigation Disclosed: A Survey of \Dominating New Tongues\ Language Learning Application
- 4Nodding off is dangerous. Some animals have evolved extreme ways to sleep in precarious environments
- 5Poland Crypto Bill Clears Sejm Again, Defying President — Will “Restrictive” Rules Stick?
- The Solution to Ecological Protection: Saving Nature for People in the future
- The Appearance of Experience: Embracing the Reduced Portage Horse
- How Seniors Can Use Refunds and Motivators to Purchase a Hyundai Ioniq EV
- Dominating the Mastercard Endorsement Cycle: Six Fundamental Stages
- All that You Really want to Be aware of Dental Inserts Facilities
- New York to require social media platforms to display mental health warnings
- The Best Games On the planet
- ADHD drugs work, but not the way experts thought
- Idris Elba is the king of the stress-watch
