
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
The most effective method to Decide the Best Auto Crash Attorney for Your Lawful Necessities - 2
Instructions to Expand Your Advantages from an Open Record Reward - 3
Extremely Rare Snub-Nosed Monkey Was Just Born for the First Time Outside of Asia - 4
Monetary Strengthening: Assuming Command over Your Cash - 5
UK can legally stop shadow fleet tankers, ministers believe
6 Objections for an Ocean side Wedding
The 15 Most Motivating TED Discusses All Time
Holiday spots Well known With Americans In 2024
BravoCon 2025: How to watch, full schedule and lineup, where to stream free and more
Vote in favor of your Number one method for praising a birthday
Anger as German family business group opens talks with far-right AfD
NASA's moon mission has begun — here's what's ahead for the Artemis II astronauts
Find the Advantages of Innovative Leisure activities: Supporting Creative mind and Self-Articulation
Why the UAE has incurred the wrath of Somalia













