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June 25, 2021Toviaz Receives New Indication to Treat Neurogenic Detrusor Overactivity in Children
June 24, 2021 – The U.S. FDA has approved a new indication for Toviaz® (fesoterodine fumarate) extended-release oral tablets, manufactured by Pfizer, to treat neurogenic detrusor overactivity (NDO) in pediatric patients who are least six years old and weigh more than 25kg (55 pounds).
NDO occurs when neurological issues affect the signals sent to the bladder from the nervous system. It causes involuntary contraction of the detrusor muscle, which is also known as the bladder wall muscle, The muscle tightens to empty the bladder and relaxes to allow the bladder to store urine. Involuntary contractions can reduce the bladder’s capacity to hold urine and lead to urine leaks, frequent and urgent need to urinate, and urinary incontinence (loss of bladder control). The increased pressure on the bladder from NDO can also permanently damage the urinary tract, including the kidneys.
In a clinical study of pediatric patients diagnosed with NDO, Toviaz delivered significant improvement from baseline in maximum bladder capacity at Week 12. Patients on Toviaz also had improvements in bladder pressure, involuntary bladder spasms, number of incontinence episodes per day, and urine volume per 24 hours.
Recommended dosing under the new indication is based on factors such as the patient’s weight, renal health, and other medications they may be taking. Toviaz is taken by mouth once daily.
First FDA approved in 2008, the drug is also indicated to treat overactive bladder (OAB) in adults who have symptoms of urge urinary incontinence, urgency, and frequency.