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
Climbing Mount Everest: An Individual Victory - 2Best Exciting ride: Which One Rushes You the Most?
- 3In blow to Lula, Brazil Congress revives controversial environmental bill
- 4Telecommute Arrangement: What's Pivotal for Your Efficiency?
- 5Old age isn’t a modern phenomenon – many people lived long enough to grow old in the olden days, too
- Misremembering might actually be a sign your memory is working optimally
- Zelensky sees new Russian attack threat from Belarus
- Phonetic Associations: A Survey of \Interfacing Worldwide People group\ Language Trade Application
- Upgrading the Healthy benefit of Your Local Vegetables
- Savvy Tips for Seniors Hyundai IONIQ EV
- Ukrainian troops showed 'greater tactical imagination' than Western trainers, British officer says, pointing to their ambush tactics
- Korean Air takes emergency action as fuel prices soar
- Vote In favor of Your Favored Menial helper Administration
- Remain Fit: Powerful Wellness and Work-out Schedules for a Better You
