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
Here's what can happen if you drive under the influence of pot - 2Anthony Joshua's driver charged over Nigeria crash that killed two
- 3NASA chief Jared Isaacman says Texas may get a moonship, not space shuttle Discovery
- 4How a cocktail of rogue storms and climate chaos unleashed deadly flooding across Asia
- 5The 15 Most Rousing TED Chats on Self-awareness
- A Time of Careful Eating: Individual Tests in Nourishment
- Why this Iranian island looks like Mars after it rains
- The Most Rousing Ladies Business visionaries of Today
- Exploring the Gig Economy: Illustrations from Consultants
- Greenland’s melting ice and landslide-prone fjords make the oil and minerals Trump is eyeing dangerous to extract
- The most effective method to Promoter for Cutthroat Medical attendant Compensations in Your Medical services Office
- Pope Leo XIV calls for urgent climate action and says God’s creation is 'crying out'
- The Job of Attorneys: It is Important to Comprehend When Legitimate Help
- How much should a kid's birthday party cost? One mom spent $190 for pizza and ice cream at a park. Another paid $2K for a playspace and goodie bags.
