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
Creativity Revealed: A Survey of \Making Shocking Looks\ Cosmetics Item - 2A mom stopped giving her kids snacks — and sparked a debate about eating habits
- 3EU chief urges Iran to free imprisoned protesters, lift internet ban
- 4Cocoa Prices Sink on Favorable Crop Conditions in West Africa
- 5What causes RFK Jr.’s strained and shaky voice? A neurologist explains this little-known disorder
- Figure out how to Put resources into Lab Precious stones: A Novice's Aide
- What's Your Number one Superhuman Film Made?
- Geminid meteor shower, one of the year's most reliable, peaks this weekend
- Find the Specialty of Calligraphy: Dominating the Exquisite Art of Penmanship
- Step by step instructions to Contrast Lab Precious stones and Normal Jewels
- What's your #1 tone
- Dancing through the crackdown: The satirical song soundtracking post-Khamenei Iran
- 2 ways you can conserve the water used to make your food
- Vote In favor of Feasible Way You Prescribe to Shop for Garments
