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
The most effective method to Examine a Cellular breakdown in the lungs Finding with Family - 2Hot peppers sent him to the ER. Two years later, a ‘ghost bill’ arrived.
- 3Dwayne ‘the Rock’ Johnson opens up about being the 'new guy' again — and why this moment feels like a new life
- 4The most effective method to Decisively Use Open Record Rewards
- 5Gaza humanitarian efforts reach key milestone as UNICEF vaccinates some 13,000 children
- The Way to Fruitful Weight reduction: Individual Wellbeing Excursions
- Gov’t approves millions for border cities in North under Hezbollah fire
- Solar storms have influenced our history – an environmental historian explains how they could also threaten our future
- Limited Rain Chances in Brazil Boost Coffee Prices
- From Squid Game to Your Party! Six Entertaining Test Games That Will Have You in Join
- Saudi Arabia says it intercepted 7 missiles, debris falls near energy facilities
- Find the Insider facts of Compelling Systems administration: Building Associations for Progress
- Countdown to Artemis II: What to know about NASA's moon mission
- Osteoporosis, the silent disease, can shorten your life − here’s how to prevent fractures and keep bones healthy
