
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
Far-right German youth group delegates seek deportations, remigration - 2
What causes RFK Jr.’s strained and shaky voice? A neurologist explains this little-known disorder - 3
Novo Nordisk cuts Wegovy price as CEO pledges to go 'all in' on weight loss pill - 4
The Main 20 Gaming Control center Ever - 5
Massachusetts court hears arguments in lawsuit alleging Meta designed apps to be addictive to kids
Study reveals how fast weight returns after ending GLP-1 drugs
Manual for 10 Scrumptious Specialty Mixed drinks
The Eastern Bongo, Kenya’s Rare Forest Antelope on the Brink
Energy agency chief warns of 'black April' for oil supplies
Astonishing interstellar comet captured in new images by NASA Mars missions
Figure out how to Team up with Your Auto Crash Legal advisor for Best Outcomes
Step by step instructions to Pick the Right Web-based Degree Program
Top 15 Web-based Entertainment Stages for Individual Marking
UN panel says Israel operating 'de facto policy of torture'













