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
Israel says it killed armed Hamas 'terrorists' in Gaza - 2This widow influencer is using jokes to cope after her husband's death. It's OK if people don't get it.
- 3Astronauts on the ISS watched NASA's historic Artemis 2 launch from space
- 4Watch Atlas V rocket launch its heaviest-ever payload early on April 4
- 5The Response to Self-improvement: Embracing a Development Outlook
- Simple Consideration Plants for Home and Office: An Aide
- American Airlines Flight Attendant Disappears Amid Layover in Colombia, Authorities Investigating
- Supportive Tips On Home loans For First-Time Home Purchasers
- Sixteen Kenyans missing in Russia after army recruitment
- Book excerpt: "Eat Your Ice Cream" by Ezekiel J. Emanuel, M.D.
- Instructions to Help a Friend or family member Determined to have Cellular breakdown in the lungs
- Cuba fights to contain spread of mosquito-borne chikungunya virus
- Oprah Winfrey's Favorite Wellness Destination Is A Luxurious Italian Retreat
- Vote In favor of Your Favored Kind Of Tea
