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
Vote In favor of Your Number one Sort Of Blossoms - 2Instructions to Pick the Right Dental Embed Trained professional: An Exhaustive Aide
- 3Parents who delay baby's first vaccines also likely to skip measles shots
- 4I'm 18 and founded an AI startup. I have to wake up at 3 a.m. to work on it before school, but it's worth every sleepless night.
- 5Top 20 Wellbeing and Wellness Applications for a Sound Way of life
- Remains of banker missing since 1999 found on California beach by family looking for seashells
- ‘Serving is not just a place’: Bayside Church Granite Bay reimagines annual mission amid conflict in Mexico
- China Just Got Another Cheap EV America Would Love to Have
- Here's what can happen if you drive under the influence of pot
- Step by step instructions to Guarantee Your Internet Promoting Degree Supplements Your Profession Objectives
- Equality requires universal draft, participation in economy and workforce, MK Liberman says
- The Delight of Camper Vans: Choosing the One That Meets Your Requirements
- How much should a kid's birthday party cost? One mom spent $190 for pizza and ice cream at a park. Another paid $2K for a playspace and goodie bags.
- The Difficulties of Getting a Green Card in the US
