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
9 Under-The-Radar Malaysian Islands To Consider Instead Of Thailand Or Indonesia - 2NASA's Voyager 1 set to achieve historic distance from Earth
- 3Fisherman Attacked by Great White Shark Says ‘My Left Foot Was in His Mouth’
- 4Israel kidnaps PIJ terrorist in covert op. in Hamas-controlled Gaza in pursuit of Ran Gvili
- 5Europe’s Airlines Run Low on Fuel
- Exclusive new photos from 'Michael' biopic show Jaafar Jackson as King of Pop
- 10 Activities to Lift Your Consume and Bust Your Stomach
- 4 DSLR Cameras for Amateurs in 2024
- From blowouts to big interiors, ‘Tuscan Mom’ style is Gen Z’s answer to beige burnout
- The 25 Most Notable Style Crossroads in History
- Doctor's orders? ‘Belly laugh at least two to five days a week'
- New materials, old physics – the science behind how your winter jacket keeps you warm
- Step by step instructions to Pick the Right Dental specialist for Your Dental Inserts Technique
- Charity 'feels the pinch' of higher energy prices
