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
How many ships have been attacked in the Gulf since start of Iran war? - 2One third of Spanish pork export certificates blocked since swine fever outbreak, minister says
- 3Report: Thailand strikes deal with Iran for safe passage of Hormuz
- 4IDF strikes Tehran command centers, weapon production sites
- 57 Well known Vacation spots In The US
- Giant ‘toothed’ birds flew over Antarctica 40 million to 50 million years ago
- Is Chinese food truly flavorful?
- Ariana Grande says Eternal Sunshine 2026 tour will be her last for a 'long, long time': 'One last hurrah'
- Doctored NXT Summit footage falsely portrays Modi as declaring war on Iran and Pakistan
- Sentimental tree to shine at Arctic League annual broadcast
- Israel strikes Iranian nuclear development facilities, Tehran vows retaliation
- Yemen's Houthis ready to join Iran war if needed, raising new shipping risk
- Brazil's ex-president Bolsonaro operated on for hernia
- The Response to Independence from the rat race: Methodologies for Creating Financial momentum
