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
The Job of a Migration Legal advisor: How They Can Help You - 2Tributes pour in for MIT professor Nuno Loureiro amid unresolved shooting case
- 3As nations push for more ambition at climate talks, chairman says they may get it
- 4Experience Unrivaled Sound: Top Speakers You Really want to Hear
- 5Hamas Navy head, engineer of Khan Yunis tunnel network killed in Gaza, IDF confirms
- James Webb Space Telescope watches our Milky Way galaxy's monster black hole fire out a flare
- Genome study reveals milestone in history of cat domestication
- Brazilian cardinal orders a popular Catholic priest to go offline following right-wing attacks
- Scientist turns people’s mental images into text using ‘mind-captioning’ technology
- Top Pastry: What's Your Sweet Treat of Decision?
- Go With The Breeze: Grand Paragliding Spots On the planet
- 5 Signs Now is the ideal time to Update Your Android Telephone: When to Take the Action
- How will the universe end?
- A definitive Manual for the Over-Ear Earphones
