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
Are protests pushing Iran's Islamic regime toward a tipping point? - 2Individual Preparation Administrations to Raise Your Wellness Process
- 3Language Learning Stages: Which One Gets Your Vote?
- 4Unwinding History's Secrets: Looking for the Response to Antiquated Human advancements
- 5Birds at a college changed beak shapes during the pandemic. It might be a case of rapid evolution
- Bolsonaro briefly leaves Brazilian prison for medical tests after a fall from his bed
- Takeda's AI-crafted psoriasis pill succeeds in late-stage studies
- Pick Your Favored kind of sandwich
- Mars orbiter sees 'butterfly' crater spread its wings on the Red Planet
- Six Flags Opens the Tallest, Fastest and Longest Roller Coaster in the World
- Palestinians tell BBC they were sexually abused in Israeli prisons
- Ageless Tastefulness: An Outline of Valuable Gemstones and Adornments
- Step by step instructions to Remain Spurred While Chasing after a Web-based Degree
- Desired Travel Objections Worldwide: Where to Go Straightaway
