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
6 Solid Vehicle Fix Administrations to Keep Your Vehicle in Prime Condition - 2Mars spacecraft images pinpoint comet 3I/ATLAS's path with 10x higher accuracy. This could help us protect Earth someday
- 3Flourishing in a Remote Workplace: Individual Techniques
- 4Health Rounds: Regeneron drug wipes out residual multiple myeloma cells in small trial
- 5Watch Chinese astronauts enjoy '1st ever space BBQ' from Tiangong's brand-new oven (video)
- World’s tallest bridge and biggest museum named ‘greatest places of 2026’
- Robert Irwin on winning 'Dancing With the Stars' 10 years after sister Bindi: 'This was everything I dreamed it would be and so much more'
- One perk to marrying Richard Marx later in life? 'We don't have time' for stupid arguments, says Daisy Fuentes.
- World leaders, rights groups react to COP30 climate deal
- RFK Jr. says he's following 'gold standard' science. Here's what to know
- Get Cooking: 15 Speedy and Heavenly Recipes for Occupied Individuals
- Former GLP-1 users regain lost weight after about 18 months, study says
- Figure out How to Get the Best Open Record Rewards
- Sound Maturing: Wellbeing Tips for Each Life Stage
