
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
6 Famous kind of practice on the planet06.06.2024 - 2
Opening Potential: Self-awareness and Long lasting Learning06.06.2024 - 3
The Way to Recuperation: Defeating Dependence25.09.2023 - 4
An Extended time of Careful Nurturing: Individual Bits of knowledge on Bringing up Kids05.06.2024 - 5
10 Distinct Kinds of Chinese Neighborhood Specialty Hot Pot05.06.2024
A Manual for Pick High Evaluated Food Conveyance Administrations In Significant Urban communities For 2024
Elvis Presley's Infamous Pantera Shooting
Doctors seek to understand why quitting antidepressants causes withdrawal for some
IDF finds weapon of slain hostage Capt. Daniel Perez in booby-trapped Gaza compound
Is an $85 apple pie worth it? Our Thanksgiving taste test says … maybe.
Qantas and Virgin Australia Ban Power Bank Usage on Flights Following Safety Incidents
Astronaut on ISS captures spectacular orbital video of zodiacal light, auroras and the Pleiades
Scientists uncover an ant assassination scheme that helps a parasitic queen rise to power
Best Pizza Beating: What's Your #1?













