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
As tetanus vaccination rates decline, doctors worry about rising case numbers - 24 Must-Visit bar-b-que Eateries This Year
- 3Bismuth’s haredi draft bill won’t change enlistment, IDI expert tells 'Post'
- 4FDA approves Wegovy pill for weight loss: What to know
- 5Paratroopers kill terrorist who threw rocks at Israeli citizens, soldiers near Ofra in West Bank
- 37 Things Just Individuals Experiencing childhood during the 80s Will Comprehend
- 2 new malaria treatments announced as drug resistance grows
- Research institutions tout the value of scholarship that crosses disciplines – but academia pushes interdisciplinary researchers out
- Shrewd Home Gadgets to Save Energy
- Well known Travel Booking Locales: What's Your Pick?
- In the background: Visiting Notable Film Areas All over the Planet
- Best Internet based Course for Learning Another Dialect: Which Stage Do You Like?
- Signature Scents: A Manual for Outstanding Fragrances
- Supreme Court case about ‘crisis pregnancy centers’ highlights debate over truthful advertising standards
