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
New dinosaur tracks in Italy illustrate herds moving in unison - 2Turkey key underlying issue as Israel, Greece, Cyprus hold summit
- 3Pick Your #1 Kind Of Treat
- 4The newest 'Project Hail Mary' trailer shows Ryan Gosling befriending an alien in Phil Lord and Chris Miller's space epic
- 5Taylor Frankie Paul's domestic violence case is fueling discussions about DARVO. Experts say terms like this shouldn't be used lightly.
- Flourishing in a Cutthroat Work Market: Vocation Methodologies
- Investigation reveals sperm donor passed on cancer risk to dozens of children across Europe
- Aluminum salts emerge as likely target as health officials scrutinize childhood vaccines
- Exclusive new photos from 'Michael' biopic show Jaafar Jackson as King of Pop
- The Land Rover Freelander Is Back—But It’s No Longer a Land Rover
- Modern surgery began with saws and iron hands – how amputation transformed the body in the Renaissance
- Step by step instructions to Lessen Your Gamble of Creating Cellular breakdown in the lungs
- These four astronauts could soon travel farther from Earth than anyone has gone before
- Journey Travel Objections for Your Next Experience
