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
The Appearance of Experience: Embracing the Reduced Portage Horse - 2A Texas GOP congressman is retiring. Trump just endorsed his identical twin to replace him.
- 3Triple polar vortex to plunge central and eastern U.S. into Arctic cold through mid-December
- 41,000-mile Saharan dust storm, from the sky and from the ground
- 5Don't miss the waxing moon swing by the Beehive star cluster March 27
- Drones, physics and rats: Studies show how the people of Rapa Nui made and moved the giant statues – and what caused the island’s deforestation
- Flu activity in US could continue to rise for weeks, top CDC epidemiologist says
- My Excursion to Monetary Autonomy: Awesome ways to save cash
- Netflix is releasing a documentary on Elizabeth Smart. What to know about her kidnapping, rescue and where she is now.
- 19 Strange Motion pictures You Shouldn't Watch With Your Mum
- Golden Globes 2026 full nominations list: 'One Battle After Another' and 'The White Lotus' lead in film and television categories
- Scientists may be overestimating the amount of microplastics in the environment – and the culprit is lab gloves
- Do-It-Yourself Home Style on a Careful spending plan: Imaginative Thoughts and Tasks
- Figure out How to Back Your Rooftop Substitution
