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
Infants will no longer receive hepatitis B vaccine at birth, CDC announces - 2Pick Your #1 Kind Of Bread
- 3PHOTO ESSAY: Scientists trying to unravel one of the body's biggest mysteries
- 4Lift Your Style: Famous Hairdos for Ladies
- 5A somber Thor is returning for 'Avengers: Doomsday': Watch the dread-filled teaser
- Lebanon’s Hezbollah and Yemen’s Houthis join Iran in strike on Israel
- Several Israelis attempt to cross into Gaza, escorted back to Israel by IDF
- Favored Chinese Dish: Make Your Determination
- Best Getaway destination: Ocean side, Mountain, or City
- UK forecast to face weaker growth and higher inflation from Iran war
- Extraordinary Snowboarding Objections All over the Planet
- Figure out How to Establish a long term connection with Your Handshake
- Major Scottish gangland figure Steven Lyons arrested in Bali
- Flight cancellations: Full list of 40 airports hit by FAA cuts amid government shutdown
