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
Cygnus XL brings cargo to the ISS for 1st time | Space photo of the day for Dec. 1, 2025 - 2Investigating the World's Chief Authentic Urban communities to Visit
- 3Figure out How to Clean and Really focus on Your Lab Jewel
- 4Jill Hennessy was a '90s TV staple. Now she's in her fearless era.
- 5Sound and Delightful: 12 Nutritious Smoothie Recipes
- No respite for German economy as experts slash forecast over Iran war
- King Charles shares cancer treatment update, says it's a 'personal blessing'
- From White Elephant to Favorite Things parties, here are all the rules you need to know every kind of gift exchange
- FDA approves Wegovy pill for weight loss
- Why the chemtrail conspiracy theory lingers and grows – and why Tucker Carlson is talking about it
- This star-forming galaxy is blowing out powerful winds topping 2 million mph
- Vote in favor of your Number one kind of juice
- Vote in favor of your #1 Kind of Cap
- Reports: Nepal's former PM arrested over deadly protest crackdown
