The United States Food and Drug Administration (FDA) has granted approval to Japan-based Astellas Pharma's VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, intended for the treatment of neurogenic detrusor over-activity (NDO) in children aged two years and older, it was reported on Tuesday.
Christine P Nguyen, MD, acting director, FDA's Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research, said, 'This is the first FDA-approved treatment for NDO patients as young as two years of age. In addition, prior to today's approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing.'
The product's efficacy was based on two clinical trials with a total of 95 paediatric NDO patients, ages two to 17 years old. The studies were intended to measure the maximum amount of urine the bladder could hold after 24 weeks of treatment.
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