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
Who is behind Al-Majd, the Israeli-linked evacuation group sending Gazans to South Africa? - 2What's the Fate of 5G Innovation?
- 3Get To Be familiar with The Historical backdrop Of Western Medication
- 4Historic underwater structure discovered by divers off French coast
- 5Four countries to boycott Eurovision 2026 over Israel’s inclusion
- Figure out How to Amplify the Resale Worth of Your Kona SUV
- Reviving Your Home with Nutritious Indoor Plants
- Find the Future of Outsourcing: Exploring the Gig Economy
- Plane Passenger Allegedly Includes ‘Bomb Threat’ in Hotspot Network Name, Forces Flight to Make Emergency Landing
- 6 Agreeable Earphones To Wear
- ISS astronaut evacuation shouldn't interfere with upcoming Artemis 2 moon mission, NASA chief says
- FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
- Turning into a Sharp Financial backer: Individual budget Wins
- Vote in favor of your Number one method for commending a birthday
