NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended-release) kidney transplant recipients and 689 (393 tacrolimus extended-release) liver transplant recipients conducted in the United States, Canada, Europe, Australia, Brazil and New Zealand, among other sites. Based upon the September receipt of the NDA submission, the FDA Prescription Drug User Fee Act review date will be July 21, 2013.
"The NDA acceptance for tacrolimus extended-release capsules marks an important step toward addressing the unmet treatment need for transplant recipients who have difficulty controlling their immunosuppression drug levels with existing products," said Roy First, Astellas Global Therapeutic Area Head for Transplantation. "Astellas has been committed to the field of immunology for more than 20 years and plans to continue that commitment by working to bring promising new treatments for patients to market."
Astellas US is a subsidiary of Tokyo-based Astellas Pharma, a pharmaeutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.