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
Photos of amputees in Gaza, struggling to survive after losing limbs to Israeli airstrikes - 2The 15 Most Compelling Books in History
- 3Understanding Various Sorts of Financial balances: An Extensive Outline
- 4Which Film Has the Incomparable Melodic Score?
- 5Kona SUV: Exploring the Future with Hyundai's Visionary Hybrid
- How Would You Like to Deal with Your Funds?
- Figure out how to Put resources into Lab Precious stones: A Novice's Aide
- Ocean side Objections: Staggering Waterfront Breaks
- Southern Californians, your health insurance costs could rise in 2026
- Hezbollah field commander killed in IDF strikes in Beirut
- Greece eyes migrant repatriation centres outside the EU
- Electric Vehicles for Eco-Accommodating Driving
- Israel's Druze use AI to present to UN testimonies of 'sexual terrorism' against Syrian Druze women
- Vote In favor of Your Number one Game Control center
