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
6 Pet Sitting Administrations for Your Cherished Pets - 22023's Best 10 Cell phone Advancements You Can't Miss
- 3Becoming Familiar with an Unknown dialect: My Language Learning Excursion
- 4Which Breakfast Enraptures Your Taste Buds? Vote
- 5Climate change is straining Alaska's Arctic. A new mining road may push the region past the brink
- Did we start the fire? A 400,000-year-old hearth sparks new questions about human evolution
- ByHeart sued over recalled formula by parents of infants sickened with botulism
- US FDA unveils new pathway to approve personalized therapies
- Figure out How to Advance Space in Your Pre-assembled Home for Upgraded Usefulness
- Sydney Sweeney is returning in 'The Housemaid's Secret': What to know about 'The Housemaid' sequel
- Must-Have Wellness Gear: What to Purchase for Successful Exercises
- 74 suicide warnings and 243 mentions of hanging: What ChatGPT said to a suicidal teen
- Why do people have baby teeth and adult teeth?
- 9 African migrants died in freezing temperatures near Morocco-Algeria border
