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
Lebanon says Israeli strike killed 13 people near Palestinian refugee camp - 2Flourishing in Retirement: Individual Accounts of Post-Vocation Satisfaction
- 3These Cities Led Global Jet-Setting In 2025, According To New Data
- 46 Famous Urban communities for Shopping on the planet
- 5The 12 biggest space stories of 2025 — according to you
- McDonald's is bringing two 'KPop Demon Hunters' meals to McDonald's. Here's what they include and when they launch.
- Top 15 Supportable Design Brands Coming out on top
- NASA Artemis 2 astronauts to make historic moon flyby today. Here's what to expect hour by hour (timeline)
- What to know as New York City nurses strike for a 3rd day
- Senegal limits foreign trips for officials as the fallout from Iran war deepens
- American Airlines Flight Attendant Disappears Amid Layover in Colombia, Authorities Investigating
- Greece eyes migrant repatriation centres outside the EU
- How Trump's marijuana executive order could change medical research landscape
- Opening Your True capacity: 12 Techniques for Personal growth
