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
IDF kills four terrorists equipped with weapons, surveillance gear near Gaza's Yellow Line - 2Doctors seek to understand why quitting antidepressants causes withdrawal for some
- 3The most effective method to Refresh the Infotainment Framework in the Volvo XC40
- 4Why screening for the deadliest cancer in the U.S. misses most cases
- 5Bismuth’s haredi draft bill won’t change enlistment, IDI expert tells 'Post'
- Top Pastry: What's Your Sweet Treat of Decision?
- Is 'Veronica Mars' about to be your new binge-watch? It's now streaming on Netflix.
- Easter Island quarry reveals how Polynesians made enigmatic stone statues
- New Year's superstitions: Eating 12 grapes, avoiding laundry and other rituals that are said to bring good fortune
- DEA seizes 1.7 million counterfeit fentanyl pills in Colorado storage unit
- 'No middle ground' for tackling antisemitism after Bondi Beach mass shooting, deputy FM Haskel says
- How to watch the ‘Wicked: One Wonderful Night’ special — now streaming
- Explainer-What has happened to the damaged spacecraft at China's space station?
- Unsold Rams May Be Less expensive Than You Suspect
