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
Congress is running out of time to extend ACA subsidies as the GOP moves on to an alternative plan. Here's where things stand. - 2From Overpowered to Coordinated: Individual Accounts of Cleaning up
- 3France's Senate backs ban on social media platforms for under-15s
- 46 Trail blazing Bicycles for Rough terrain Undertakings
- 5Latvia seeks emergency UN meeting over Russian missile attack on Lviv
- Cyclone causes blackout, flight chaos in Brazil's Sao Paulo
- Zelensky confidant dismissed from further posts amid bribery scandal
- Cameroon says Russia has confirmed 16 Cameroonian soldiers died in Ukraine
- Rick Steves Recommends This German Town's Castle Hotel With Rhine River Views
- Early Thanksgiving week forecast: Where Americans can expect cold, rain and snow for the holiday
- Israeli president concerned over proposed renaming of park
- Which Store is Your Decision ?
- Volkswagen in talks with defence firms on use of Germany plant: CEO
- Dwayne ‘the Rock’ Johnson opens up about being the 'new guy' again — and why this moment feels like a new life
