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
Baikonur launch pad damaged after Russian Soyuz launch to International Space Station - 2Former Australian soldier arrested over alleged Afghan war crimes
- 3What's going on with Katseye? The Manon Bannerman hiatus drama, explained.
- 4Metropolitan Greatness: The 6 Urban areas for Quality Living in 2024
- 5Phonetic Associations: A Survey of \Interfacing Worldwide People group\ Language Trade Application
- Tehran defends ship seizure as a legal action, but tensions continue in the Gulf
- Best Veggie lover Dinner: What's Your Plant-Based Pick?
- The Developing Nearby Food Development and Its Advantages
- 4 Dazzling And Well known Island Objections In US
- 'Heated Rivalry' is just the tip of the iceberg. How hockey became the sexiest sport
- Mechanical Sidekick d: A Survey of \Elements and Execution d\ Cell phone
- Best Amusement Park in Asia: Which One Is a Must-Visit
- Catch the moon dancing with bright star Regulus tonight
- CDC vaccine panel delays vote to stop recommending hepatitis B shot at birth
