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
We tasted one of the 10,000 Hershey's Dubai chocolate bars being resold on eBay. Is it worth the hype? - 2Dave Coulier shares new cancer diagnosis 1 year after revealing previous diagnosis
- 3UN warns civil liberties under threat due to war in Middle East
- 4Kuwait is softening stance on Israel, dissident tells ‘Post’ after viral UN speech
- 5NASA's Artemis 2 astronauts are cruising to the moon. So why are they doing CPR tests today?
- Orbán orders stop to gas deliveries to Ukraine via Hungary from July
- Mars spacecraft images pinpoint comet 3I/ATLAS's path with 10x higher accuracy. This could help us protect Earth someday
- 'We are ready': NASA still on track to launch Artemis 2 astronauts to the moon April 1
- NASA counts down for first crewed lunar mission in half a century
- Surge of off‑lease electric vehicles expected to drive down used EV prices
- Malaysia To Revive Search for Missing Flight MH370
- 6 Natural products High In Vitamins,Which One Do You Like to Eat
- New trailer for 'Bridgerton' Season 4 teases Benedict's love story: Watch it here
- Can humans have babies in space? It may be harder than expected
