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
Russia accidentally destroys its only way of sending astronauts to space - 2From Dread to Certainty: Individual Accounts of Strengthening
- 3South Carolina confirms 124 new measles cases as outbreak on the Arizona-Utah line grows
- 4South Korea president says Iran war shows the need to ditch ‘extremely risky’ fossil fuels
- 5Investigating Cooking and Culinary Expressions: An Excursion Through Flavors
- New science points to 4 distinct types of autism
- Scientists captured female sperm whales on video working together during a birth to protect the calf
- They relied on marijuana to get through the day. But then days felt impossible without it
- Believe Should Unwind? Look at These Scaled down Games
- Remain Cool and Solid: Top Summer Food sources for 2024
- Vote in favor of Your #1 Instructive Toy: Learning and Tomfoolery Joined
- IDF confirms Iranian missile fragments hit near Kirya, multiple cars ablaze in Ramat Gan
- Potential Houthi threat to Red Sea shipping could further damage global economy
- The cheap health insurance promoted by Trump officials has this catch
