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
Flights canceled at 40 U.S. airports: Follow live updates as FAA cuts to air traffic take effect amid government shutdown - 2Seven deaths possibly linked to malfunctioning glucose monitors
- 3Inside Plan with Houseplants: An Aide
- 4What happened to Eleven after the ambiguous 'Stranger Things' series finale? Millie Bobby Brown knows — but 'swore herself to secrecy'
- 5Presenting Nintendo's New Pastel Satisfaction Con Tones for Switch Gamers: 3 Upscale Choices
- 'Sex and the City' star Kim Cattrall marries longtime partner Russell Thomas in intimate London wedding
- Opening Innovativeness: Moving Thoughts and Tasks
- Vote In favor of Your Number one Savvy Beds
- Health officials report 14 Legionnaires' disease cases in Florida, gym connection suspected
- From Dread to Certainty: Individual Accounts of Strengthening
- The Best Web-based Courses for Ability Advancement
- Building a Flourishing Business: Illustrations from Business people
- Archaeologists uncover details about the Hjortspring boat's origins
- A new mom skipped a routine appointment. An infected cut led to a devastating diagnosis
