
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
What to know about the hepatitis B shot — and why Trump officials are targeting it03.12.2025 - 2
Instructions to Pick the Best Album Rates for Your Investment funds19.10.2023 - 3
Winter storm warnings issued across Northeast as up to 9 inches of snow forecast; deadly atmospheric river in California snarls travel26.12.2025 - 4
Instructions to Help a Friend or family member Determined to have Cellular breakdown in the lungs17.10.2023 - 5
Remote Work Survival manual: Helping Efficiency at Home01.01.1
Why don’t humans have hair all over their bodies? A biologist explains our lack of fur
What to know about King Charles III's cancer treatment and his message to the public
Illumina unveils dataset to speed up AI-powered drug discovery
Shah Capital pushes for Novavax sale, warns of proxy fight
The most effective method to Begin Your Excursion in Gold Venture
Stop the ‘good’ vs ‘bad’ snap judgments and watch your world become more interesting
Why Cannes Is the Ultimate New Year’s Eve Destination in the South of France’s Off-Season
Alice Wong, founder of the Disability Visibility Project, dies at 51
Don’t let food poisoning crash your Thanksgiving dinner













