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
Clones of Stumpy, Washington D.C.'s beloved cherry blossom tree, have flowered for the first time - 2Virtual Domains d: A Survey of \Inundation and Ongoing interaction Mechanics\ Computer game
- 3Philippines evacuates 3,000 villagers after volcano activity raises alert level
- 4Iran, Hezbollah fire rockets at Israel during Passover celebrations
- 5Current Chateaus: Advancement and Style
- Soldiers seize power in Guinea-Bissau and detain the president
- In the stomach of a mummified wolf pup, scientists find DNA from a woolly rhinoceros
- German Cabinet advances bill to cut greenhouse emissions from fuels
- Hitler's madcap mega-railway would have linked Berlin with India
- What is a Trump Gold Card? U.S. launches $1 million immigration visas
- Greenland’s melting ice and landslide-prone fjords make the oil and minerals Trump is eyeing dangerous to extract
- Best Amusement Park Bite: What Do You Very much want to Crunch On?
- Massive supernova explosion may have created a binary black hole
- Cases of norovirus are on the rise just in time for the holiday season
