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
Research institutions tout the value of scholarship that crosses disciplines – but academia pushes interdisciplinary researchers out - 2Emergent Cold LatAm opens state-of-the-art cold storage hub in Guadalajara
- 3Italy fertility rate fell to new low of 1.14 in 2025
- 4Flu surges across U.S. as doctor visits reach highest level since 1997
- 5Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks
- NASA is shooting for the moon. A guide to the Artemis II mission
- Air travelers face higher ticket prices as Iran war drives up oil prices
- Remote Work Survival manual: Helping Efficiency at Home
- Iran warns its ready to open new front in Yemen, close Bab al-Mandab Strait with Houthis
- The most effective method to Make a Dazzling Site in 5 Basic Advances
- Crypto Investor’s Family Tied Up and Beaten by Armed Gangs in Their Home
- NASA begins the countdown for humanity's first launch to the moon in 53 years
- Surging measles cases are 'fire alarm' warning that other diseases could be next
- Well known SUVs With Low Energy Utilization In 2024
