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)
7 Strange Apparatuses to Make Your Party Stick Out!- January’s full wolf supermoon and the Quadrantid meteor shower will start off the new year
- I tried a macho, creatine-loaded cereal “for men.” Did I mention I'm a woman?
- MacArthur Foundation awards $100M to outbreak surveillance network, a boost amid global health cuts
- New materials, old physics – the science behind how your winter jacket keeps you warm
- Blue Origin's next space tourism flight will break new ground for people with disabilities
- Deadly heat worldwide prompts $300 million for climate health research at COP30
- Instructions to Warmly greet Certainty and Appeal
- Vote in favor of your Favored sort of footwear
