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)
Like many holiday traditions, lighting candles and fireplaces is best done in moderation- Astonishing Deserts All over The Planet You Really want To Visit
- Woman gives birth on roadside after hospital allegedly sent her home: Family
- When a sperm whale gives birth, the mother gets help from her friends
- Air India chief resigns 10 months after devastating Ahmedabad crash and amid mounting financial troubles
- Last supermoon of the year, the cold moon, seen across the U.S.: See the photos
- Paris Agreement target off the table, report says
- The Force of Systems administration: Individual Examples of overcoming adversity
- NASA, in a rare move, cuts space station mission short after an astronaut's medical issue
