
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
Israel's Druze use AI to present to UN testimonies of 'sexual terrorism' against Syrian Druze women10.12.2025 - 2
Ethiopian earthquakes and volcanic eruptions: earth scientist explains the link26.11.2025 - 3
I was about to film a movie with Glen Powell when my hair started falling out in clumps. Alopecia has made me unrecognizable as an actor.01.12.2025 - 4
Investigating the World's Chief Authentic Urban communities to Visit06.06.2024 - 5
Some gifted dogs can learn new toy names by eavesdropping on owners08.01.2026
Experience Arranging: Planning for Epic Excursions
Raw oysters linked to ongoing salmonella outbreak infecting 64 across 22 states: CDC
Former school bus aide pleads guilty to assaulting 3 autistic students in Colorado
A definitive Manual for Picking Electric Vehicle: Decision in favor of Your Number one
Purdue Pharma's deal means money for some victims, end of Purdue company name. Here's what to know
The most effective method to Connect Successfully with Teachers in a Web based Setting
When preventable infections turn deadly behind bars | The Excerpt
Catholic influencer shares death of 5-year-old son from 'severe' flu
Rick Steves Prefers Paying A Bit Extra For This Delectable Food When Dining In Spain













