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
France honors the victims of the Paris attacks' night of terror 10 years on - 2Savvy Cleaning: The 6 Robot Vacuums of 2024
- 3Hubble Space Telescope spies dusty debris from two cosmic collisions
- 4James Webb Space Telescope watches 'Jekyll and Hyde' galaxy shapeshift into a cosmic monster
- 5Commonsense Ways to work on Your Funds with a Restricted Pay
- The Development of Shipping: Controlling Towards a More Associated Future
- The Most Astonishing Arising Advancements to Watch
- Early Thanksgiving week forecast: Where Americans can expect cold, rain and snow for the holiday
- From candy cane fishing to ornament switcharoo, here are some of the best games you can play with your loved ones this holiday season
- Woman shocked to welcome baby after experiencing stomach pain on Christmas
- Monetary Freedom Guide: Plan Your Future
- They grew up with 'almond moms.' Now, they dread going home for the holidays.
- Selena Quintanilla documentary 'Selena y Los Dinos: A Family's Legacy' is coming to Netflix
- Lower-cost space missions like NASA's ESCAPADE are starting to deliver exciting science – but at a price in risk and trade‑offs
