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
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths - 2Lebanon’s Hezbollah and Yemen’s Houthis join Iran in strike on Israel
- 3Astonishing Deserts All over The Planet You Really want To Visit
- 4Pfizer in $41.5 million settlement with Texas over ADHD drug for children
- 5Inside Kathy Hilton’s Christmas pajama party: caviar bumps, champagne vending machines and a mansion full of Housewives
- Reports: Nepal's former PM arrested over deadly protest crackdown
- This Week In Space podcast: Episode 189 — Privatizing Orbit
- The Eastern Bongo, Kenya’s Rare Forest Antelope on the Brink
- At least 18 Palestinians killed in latest clashes in Gaza
- Vote in favor of Your Number one Cake Type
- Americans generally like wolves − except when we’re reminded of our politics
- The many ways that baking is winter therapy. With a delicious ending
- Figure out How to Streamline Eco-friendliness in Your Volvo XC40
- 'Seditious behavior': Trump accuses Democrats who made video reminding the military not to follow illegal orders of a crime — but is it?
