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
Poll: 62% of Americans would oppose U.S. military action in Greenland - 2FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
- 3Etymological Experiences on the Wireless transmissions: A Survey of \Learning in a hurry\ Language Web recording
- 4Figure out How to Modify Your Pre-assembled Home for Greatest Solace and Stylish Allure
- 5Would you ever turn to AI for companionship? 6% of Americans say they could — or already have.
- Agricultural drones are taking off globally, saving farmers time and money
- Which European palace do you fantasy about visiting? Vote!
- I binged all 24 Hallmark Christmas movies in less than 30 days. I emerged a changed man.
- Instructions to Choose the Best Web based Advertising Degree Program for Your Objectives
- One dead, six wounded in various crime-related shootings in Israel over the weekend
- The Manual for Electric Vehicles that will be hot merchants in 2023
- New dietary guidelines recommend more dairy, meat and fats: What to know
- Support Your Investment funds with These Individual accounting Thoughts
- Consumers advised to dispose of 19 cooking pans due to lead leaching risk, FDA reports
