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
The 10 Most Noteworthy Games in History - 2Russian drone slams into block of flats in deadly wave of strikes across Kyiv
- 3A red meat allergy from tick bites is spreading – and the lone star tick isn’t the only alpha-gal carrier to worry about
- 4Scientists captured female sperm whales on video working together during a birth to protect the calf
- 5Banks for High Fixed Store Rates: Augment Your Investment funds
- Flu cases are rising with a strain that makes older people sicker
- Analysis-From 'Icarus bug' to flawed panels: Airbus counts cost of relying on single model
- Lilly becomes first healthcare firm to join trillion-dollar club, Wall Street reacts
- Manual for Savvy Home Lighting Framework: Lights up Your Space
- Crypto Investor’s Family Tied Up and Beaten by Armed Gangs in Their Home
- Pick Your Favored kind of books
- The Best Web-based Courses for Ability Advancement
- 'Backward and upward and tilted': Spaceflight causes astronauts' brains to shift inside their skulls
- Ukrainian drones hit all three Baltic States − did Russia redirect them?
