
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
Old food pyramid vs. RFK Jr.'s new food pyramid. See what's different.07.01.2026 - 2
Most loved Amusement Park for Small children: Which One Do You Suggest?01.01.1 - 3
Step by step instructions to Guarantee Your Fender bender Legal counselor has Areas of strength for a Record19.10.2023 - 4
How comfort foods trigger pleasure in our brains23.11.2025 - 5
Space station changes command, setting stage for Crew 11 departure12.01.2026
'The Beast in Me' arrives on Netflix: Is it based on a true story? And what drew Claire Danes to it? What to know about the thriller series.
Oldest sequenced RNA reveals details about a mammoth’s final moments 40,000 years
Investigating the Advantages of a Bank account: A Complete Aide
Jasmine Crockett in, Colin Allred out: A major shakeup for Democrats in their quest to finally win a Senate seat in Texas
Eli Lilly weight-loss drug appears to suppress binge-eating signal, small study finds
New movies to watch this weekend: See 'Wake Up Dead Man: A Knives Out Mystery' in theaters, rent 'Bugonia,' stream 'Caught Stealing' on Netflix
'I carried my wife's body for an hour and a half' - BBC hears stories of protesters killed in Iran
Figure out How to Adjust Your Handshake to Various Societies
Ukraine: Russians abduct 50 Ukrainians from border village in Sumy











