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
State asks High Court to reject challenge to anti-UNRWA laws ahead of Monday hearing - 2US FDA declines to approve Corcept's drug for rare hormonal disorder
- 3Climate leaders are talking about 'overshoot' into warming danger zone. Here's what it means
- 4Jillian Michaels put me at the center of a body positivity debate. She's not entirely wrong about obesity.
- 5The Golden Globes gift bag has nearly $1 million worth of swag for some winners and presenters. What's in it?
- How a toxic self-improvement trend with a funny name took over your feed
- Figure out How to Use Your Nursing Abilities for Better Compensation
- Vote In favor of Your Favored Menial helper Administration
- The Tradition of Stone: A Gander at Notable Structures Through the Ages
- New materials, old physics – the science behind how your winter jacket keeps you warm
- Deaths reported in Lebanon as Israel and Hezbollah exchange attacks
- 2024's Hot Games: Must-Play Titles of the Year
- In wrangling dark matter, some scientists find inspiration in the Torah, Krishna and Christ
- Let them eat (Taylor Swift) cake: The baker turning A-listers into life-size desserts
