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
The race to mine the moon is on – and it urgently needs some clear international rules - 2Elite Execution Wall televisions for Film Darlings
- 3Step by step instructions to Analyze Senior Insurance Contracts Really.
- 4Palestinian leader Abbas says elections only after Gaza war ends
- 5The Leonid meteor shower is peaking early this week. Here’s what to know
- This Overlooked Predator Is Running Out of Time—Why Conservationists Are Racing to Save the Striped Hyena
- See the famous winged horse Pegasus fly in the autumn night sky
- Flu season is ramping up, and some experts are "pretty worried"
- Floods, Landslides Triggered By Heavy Rain In Afghanistan Leave 77 Dead In 10 days, Authorities Say
- 'A perfect storm': Airlines cut flights and increase airfares as jet fuel price spikes
- The most effective method to Safeguard Your Teeth from Acidic Food varieties and Beverages
- Mating injuries may lead scientists to identify dinosaurs’ sex
- 'Stranger Things' made him a heartthrob. He left Hollywood anyway.
- Commonsense Ways to work on Your Funds with a Restricted Pay
