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
Figure out How to Explore Land Close to 5G Pinnacles - 2Dependable Savvy Locks to Update Your Home Security
- 3Which camera do you believe is great for first-time clients? !
- 4Pope Leo XIV calls for urgent climate action and says God’s creation is 'crying out'
- 5IDF kills senior PIJ Gaza City Brigade cmdr. who infiltrated Kibbutz Nahal Oz on Oct. 7
- Ober Gabelhorn glacier reveals remains of man missing for over three decades
- Startled Venezuelans express relief but also fear after Maduro arrest
- The Best Music Collections of the 10 years
- Vote In favor of Your Favored Kind Of Organic product
- Alleged Huione Group Money Laundering Boss Extradited to China
- A Manual for Pick High Evaluated Food Conveyance Administrations In Significant Urban communities For 2024
- How to sound like an astronaut as you follow the first human moon mission in more than half a century
- Excited visitors for NASA's moon launch jockey for prime views
- Bird flu poses risk of pandemic worse than COVID, France's Institut Pasteur says
