
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
At UN climate conference, some activists and scientists want more talk on reforming agriculture - 2
Herzog, German Chancellor Merz discuss final Gaza hostage, Arrow 3 exchange in Jerusalem - 3
Eating Brie, Gouda, cheddar may lower dementia risk, new study says - 4
How to identify animal tracks, burrows and other signs of wildlife in your neighborhood - 5
CDC vaccine panel delays vote to stop recommending hepatitis B shot at birth
In the stomach of a mummified wolf pup, scientists find DNA from a woolly rhinoceros
Massachusetts court hears arguments in lawsuit alleging Meta designed apps to be addictive to kids
What to watch for in weight loss drugs in 2026
Vote in favor of Your Number one BWM Vehicles
The most effective method to Boost Eco-friendliness in Your Volvo XC40
Figure out How to Explore Your Direction to the Best Dental Embed Trained professional: A Far reaching Manual
10 Hints for a Fruitful New employee screening
Wegmans recalls mixed nuts over salmonella contamination fears
The Significance of Health Projects in Senior Protection.













