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
Ancient Egyptian pharaoh's boat is being reassembled in public at the Grand Egyptian Museum - 2The Artemis II launch is tonight. Here's how to watch it live.
- 3Exploring the Difficulties of Co-Nurturing: Individual Bits of knowledge
- 4Must-See Attractions in France
- 5Kendall Jenner addresses long-standing rumor about her sexuality
- 6 Savvy Locks for Lofts
- German-Polish man charged with calling for attacks on top politicians
- I'm 18 and founded an AI startup. I have to wake up at 3 a.m. to work on it before school, but it's worth every sleepless night.
- How Much Has the Iran War Cost the Average American Per Day?
- Share your pick for the miniature headphones that you generally suggest!
- Artemis II astronauts find hidden Easter eggs as they close in on the moon
- Lula’s former human rights minister formally accused of sexual misconduct
- Vote In favor of Your Favored Pet Consideration Administration
- Volkswagen Plant Could Pivot From Building Cars to Supporting Iron Dome Systems
