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
Figure out How to Introduce Sunlight powered chargers on Your Rooftop securely - 2Internet Bookkeeping Programming for Consultants
- 3Top 10 Books That Will Have an impact on Your Viewpoint
- 4Old age isn’t a modern phenomenon – many people lived long enough to grow old in the olden days, too
- 5Hypothermia claims newborn in Gaza and more babies are at risk, doctor says
- Uzbekistan launches €9.46 billion green energy push, covering nation’s power needs
- Savvy Tips for Seniors Hyundai IONIQ EV
- Ariana Grande says Eternal Sunshine 2026 tour will be her last for a 'long, long time': 'One last hurrah'
- Figure out how to Use Your Brain research Degree in the Gig Market
- The most effective method to Promoter for Cutthroat Medical attendant Compensations in Your Medical services Office
- Oil, energy and food: Which countries in Europe are most exposed to higher food prices?
- Miley Cyrus flashes a diamond ring on the red carpet, sparking engagement rumors with Maxx Morando: A timeline of their four-year relationship
- Geomagnetic storm grounds launch of Mars space weather satellites
- Full SNAP benefits must be paid ‘promptly,’ USDA tells states as government reopens
