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
We tasted one of the 10,000 Hershey's Dubai chocolate bars being resold on eBay. Is it worth the hype? - 2Report in relation to renaming Herzog Park set to be withdrawn
- 3Honda’s Biggest Flex Isn’t Its Superbikes, It’s Selling 500K Bikes In One Month
- 4She loves to give experiences. He goes for sentimental gifts. They ask an expert: What is the perfect holiday present?
- 5Google to Use Natural Gas to Power Massive Data Center in Texas
- Discovery of ancient pleasure boat reveals Egypt's maritime history
- High-Suggested Broilers For Your Homes
- Top 10 Arising Advances That Will Shape What's in store
- Figure out How to Amplify the Resale Worth of Your Kona SUV
- New movies to watch this weekend: See 'The Drama' in theaters, rent 'Wuthering Heights,' stream 'Pizza Movie' on Hulu
- Investigate These Retreats Well known With Seniors
- Robyn returns to music with 'Dopamine,' her 1st single in 7 years: 'Came to save music once again'
- Eight arrested in joint Scotland and Spain gang raids
- Los Angeles County sees significant uptick in norovirus cases, officials say
