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 Magnificence of Extraordinariness: Presenting Valuable Adornments and Gemstones - 2Experience Is standing by: History's Most noteworthy Travelers
- 3Single women risk rape and exploitation in search for better life in Europe
- 4Step by step instructions to Choose the Right Auto Crash Legal counselor for Your Case
- 5Vote in favor of your Favored kind of craftsmanship
- Sean Penn lights up, Kylie Jenner gets A-list approval and 7 other moments you didn’t see at the Golden Globes
- Tasting America: An Excursion Through Darling Cheap Food Brands
- Texas cities have some of the highest preterm birth rates in the US, highlighting maternal health crisis nationwide
- One spent $20 on candy. Another paid $700 for a custom costume. Here's how Halloween costs stacked up this year.
- Happy with Running Shoes for 2024
- Saturn shines with the waxing moon at sunset on Nov. 29
- Attorney-General to High Court: Gov’t violating draft ruling, risking rule of law
- A Gustav Klimt painting is now the most expensive piece of modern art sold at auction. The fascinating history behind the $236 million 'Portrait of Elisabeth Lederer.'
- Yasser Abu Shabab's killing raises questions about Israel's militia strategy in Gaza
