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
Opening Achievement: 8 Methodologies for Compelling Using time productively - 2Why this Iranian island looks like Mars after it rains
- 3I'm an 83-year-old yoga instructor. I'm not your typical grandma — I still work to feel fulfilled and supplement my Social Security.
- 4Jeff Bezos’ Blue Origin launches landmark Mars mission in New Glenn rocket’s first big test
- 5Kids with smartphones by age 12 are at higher risk of health issues, study finds
- Famous Versatile Brands: Your Decision
- The Secret Side of Italy: 12 Underrated Destinations Locals Don’t Want Tourists to Find
- 6 Famous Urban communities for Shopping on the planet
- Vote in favor of the Web-based Work out schedule to Keep You Fit and Sound
- Would you ever turn to AI for companionship? 6% of Americans say they could — or already have.
- It's been 20 years since MTV's golden couple split. These producers saw it all unravel.
- Top Music and Dance Celebration: Which One Gets You Going?
- The 15 Most Powerful Forerunners in Business
- Manual for Financial plan Agreeable PC
