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
Key Training: Picking a Significant for Monetary Achievement - 2Marvel's X-Men are joining the battle in 'Avengers: Doomsday': Watch the teaser
- 3Figure out How to Pick the Right Toothbrush for You
- 4Apartment Turned Into Nightmare 'Ice Castle' After Tenant Shut Off Heat Causing Pipes to Burst: VIDEO
- 5From Specialist to Proficient Picture taker: Individual Triumphs
- Rachael Ray is navigating grief this holiday season. She doesn't have time for 'negative energy' on the internet.
- 3 back-to-back storms forecast to bring snow and surges of cold air across the Midwest to the Northeast
- The 1st full moon of 2026 rises tonight! Here's what to expect from January's supermoon Wolf Moon
- Saturn's moon Titan may not have a buried ocean as long suspected, new study suggests
- Find the Advantages of Careful Eating: Developing a Sound Connection with Food
- Science is best communicated through identity and culture – how researchers are ensuring STEM serves their communities
- Exploring the Mind boggling Universe of Connections: Individual Bits of knowledge
- There was a bit of toilet trouble on NASA's Artemis 2 mission to the moon
- Vote In favor of Your Favored Shimmering Water
