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
Earth's newfound 'episodic-squishy lid' may guide our search for habitable worlds - 25 Superstar Couples That Motivate Relationship Objectives
- 35 Destinations Where Airfare Is Dropping The Most For Spring 2026, Per Dollar Flight Club Analysis
- 4The Way to Fruitful Weight reduction: Individual Wellbeing Excursions
- 5Becoming Familiar with an Unknown dialect: My Language Learning Excursion
- Cases of norovirus are on the rise just in time for the holiday season
- Iran fires one of largest barrages in weeks ahead of Passover
- The most effective method to Pick a Campervan That Offers Something else for Less
- A definitive Manual for Choosing Indoor Plants Ideal for Your Space
- Pat Finn, actor from 'The Middle,' dies at 60 after bladder cancer diagnosis
- US FDA grants market authorization to six on! PLUS nicotine pouch products
- Spain’s Picos de Europa: What to see and do in ‘the world’s most beautiful place’
- A Manual for Extravagant Vehicles Available in 2024
- 6 Well known Ladies' Fragrances On the planet
