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
Figure out How to Keep up with Oral Wellbeing During Pregnancy - 2The Significance of a Land Lawyer for Your Business
- 3New movies to watch this weekend: See 'Predator: Badlands' in theaters, rent 'Black Phone 2,' stream Guillermo del Toro's 'Frankenstein' on Netflix
- 4American tourists left stranded in the Caribbean following flight cancellations after airspace closed for Maduro operation
- 5Vice President Dick Cheney’s life followed the arc of the biggest breakthroughs in cardiovascular medicine
- RFK Jr. guts the US childhood vaccine schedule despite its decades-long safety record
- More loons are filling Maine's lakes with their ghostlike calls
- Pain at the pump for Hampton Roads residents
- Von der Leyen: Paris meeting sends signal of unity for Ukraine
- A Manual for Nations to Head out To
- The Significance of Health Projects in Senior Protection.
- ONE returns to Red Sea with new service
- 10 Asian Countries Perfect for Solo Female Travelers
- Figure out How to Assess the Unwavering quality of SUVs for Seniors
