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 Advance Space in Your Pre-assembled Home for Upgraded Usefulness - 2Investigating Cooking and Culinary Expressions: An Excursion Through Flavors
- 3Selena Quintanilla documentary 'Selena y Los Dinos: A Family's Legacy' is coming to Netflix
- 4Reconnecting with an old friend is a story of distance, loss and rediscovery
- 5Public mistrust linked to drop in deceased donor organ donations and kidney transplants
- Rick Steves' Newest Guidebook Is A Fresh Perspective On Italy Spilling The Country's Secrets
- Check out the exclusive pitch deck Valerie Health used to raise $30 million from Redpoint Ventures to automate healthcare faxes
- South Carolina's measles outbreak reaches 434 cases
- Make your choice for a definitive Christmas getaway destination!
- Flu cases are spiking earlier than usual. What you need to know.
- Experience Sports in Dubai: A Daredevil's Aide
- More than 800 flights canceled as FAA cuts traffic at 40 major airports. Here's what to know.
- Turning into a Distributed Writer: My Composing Process
- The 1st full moon of 2026 rises tonight! Here's what to expect from January's supermoon Wolf Moon
