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
Tehran defends ship seizure as a legal action, but tensions continue in the Gulf- Step by step instructions to Streamline Your Dozing Involvement in a Savvy Bed
- A Couple of Reasonable Guitars for 2024
- Tremendous Spelunking: Cool Caverns All over the Planet
- ‘The White Lotus’ sparked online interest in risky anxiety pills, study says
- 'Senseless violence' erupts at Christmas tree lighting; 4 injured
- Research highlights potential dangers of ultra-processed foods for women under 50 regarding precancerous polyps
- Germany's Deutsche Welle broadcaster declared 'undesirable' in Russia
- Figure out how to Keep up with Your Dental Inserts for Long haul Achievement
