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
Investigate the Excellence of Professional flowerbeds: A Virtual Local escort - 2Geomagnetic storm grounds launch of Mars space weather satellites
- 3Manual for extravagance SUVs for seniors
- 4South African radio presenter among five charged over Russia recruitment plot
- 5IDF kills senior PIJ Gaza City Brigade cmdr. who infiltrated Kibbutz Nahal Oz on Oct. 7
- See the moon shine with Saturn in the southern sky after sunset Dec. 26
- What's going around right now? COVID, flu, stomach bug on the rise
- One spent $20 on candy. Another paid $700 for a custom costume. Here's how Halloween costs stacked up this year.
- Emergency services search for five people last seen in missing Jeep
- Striking American and European television Projects: A Survey
- Pick Your #1 breakfast food
- 6 Web-based Course Stages for Successful Learning and Educating
- 4 Family SUVs: Joining Solace and Style
- Must-See Attractions in France
