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
Nurturing Hacks: Astuteness from Experienced Mothers and Fathers - 2Style Narratives: A Survey of \Patterns and Styles Assessed\ Design
- 3How to track NASA’s Artemis II and Orion’s journey to the moon
- 410 Demonstrated Tips to Dominate Video Altering on Your Cell phone in 2023
- 5Iranian president warns of retaliation against Gulf states
- Mummified cheetahs found in Saudi caves shed light on lost populations
- South Carolina's measles outbreak reaches 434 cases
- Famous Kitchen Finishing Styles For 2024
- The Excursion to Monetary Proficiency: Individual budget Triumphs
- Must-Have Wellness Gear: What to Purchase for Successful Exercises
- Air superiority and long-range strikes: what China's war games say about how it might assault Taiwan
- Everyone knows F1 is for the girls. I wandered into the Las Vegas desert to find out why.
- The Iran war’s energy security legacy
- What is the 'Survivor 50' Challenge? Hidden immunity idols will be up for grabs in every U.S. state.
