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
The Delight of Camper Vans: Choosing the One That Meets Your Requirements - 2Key takeaways from Sen. Bill Cassidy's interview on 'Face the Nation' with Margaret Brennan
- 3One third of Spanish pork export certificates blocked since swine fever outbreak, minister says
- 4Nutrient Rich Natural products: Lift Your Wellbeing
- 5Finding China: Four Urban areas for a Remarkable Excursion
- Paraplegic engineer becomes the first wheelchair user to blast into space
- Arctic sea ice hits lowest winter level as heat records are shattered worldwide
- Israeli strike on Gaza City vehicle kills at least four, report says
- Top Pastry: What's Your Sweet Treat of Decision?
- Instructions to Keep up with Your Traded Teeth for Life span
- 'Malcolm in the Middle' reboot releases 1st trailer, reuniting Frankie Muniz and Bryan Cranston: Watch here
- Dr. Vinay Prasad's memo raises concerns about COVID-19 vaccines and pediatric mortality
- 6 Shades Brands For Seniors
- German Winemakers Rewrite The Rules Of Riesling In A Warming World
