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
DEA seizes 1.7 million counterfeit fentanyl pills in Colorado storage unit - 2Vote in favor of Your Number one BWM Vehicles
- 3Figure out How to Get the Best Open Record Rewards
- 4Addressing sleep apnea early might decrease chances of developing Parkinson's disease
- 5Fossils unearthed in Morocco are first from little-understood period of human evolution
- Significant Elements to Consider Prior to Applying for a Mastercard: 6 Vital Contemplations
- People are getting their news from AI – and it’s altering their views
- France to build new nuclear aircraft carrier, Macron says
- From Modesty to Administration: Self-improvement in Interactive abilities
- Select Your Go-To Bluetooth Earphones
- Working out at the airport? Some fliers can already smell the sweat.
- 4 Sound blocking Earphones for Prevalent Sound and Solace
- More parents refusing this shot that prevents serious bleeding at birth
- Savvy Watches: Which One Is Appropriate for You?
