
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
Accomplishing Balance between fun and serious activities: Procedures for a Better Life - 2
Former 'Bachelorette' welcomes 1st baby via emergency c-section - 3
What happened in 'Wicked' part 1 and will there be a 3rd movie? Recap and what Ariana Grande, Jon M. Chu have said about a sequel. - 4
From Fledgling to Master: Self-awareness in a Side interest - 5
The most effective method to Begin Your Excursion in Gold Venture
Treason trial of South Sudan's suspended VP is further eroding peace deal, UN experts say
Step by step instructions to Choose the Right Auto Crash Legal counselor for Your Case
Gulf countries roll out more autonomous taxis
How a Middle East War Becomes a Retail Price Hike
Civilian toll mounts in Iran as war presses on
The Manual for Decent European Urban communities in 2024
What's the Fate of 5G Innovation?
Desired Travel Objections Worldwide: Where to Go Straightaway
European nations criticise Israel’s death penalty plans













