Astellas Receives FDA Approval for Myrbetriq (Mirabegron) as First-in-Class Treatment for Pediatric Neurogenic Detrusor Overactivity (NDO)
Mar 29, 2021 17:41
CST Updated
17:41
Astellas
Pharmaceutical R&D Manufacturer
FDA
U.S. Food and Drug Administration
March 29, 2021/BioValleyBIOON/--Japanese pharmaceutical company Astellas recently announced that the U.S. Food and Drug Administration (FDA) has approved: (1) Myrbetriq tablets (mirabegron, extended-release tablets) for the treatment of pediatric patients aged ≥3 years and weighing ≥35 kg with neurogenic detrusor overactivity (NDO); (2) Myrbetriq granules (mirabegron, oral suspension) for the treatment of pediatric patients aged ≥3 years with NDO. In addition,FDAPediatric exclusivity for Myrbetriq was also approved, thereby extending its market exclusivity period by 6 months.
Myrbetriq tablets and Myrbetriq granules were approved through the Priority Review program and are currentlyFDAThe first-in-class product approved for the treatment of children with neurogenic detrusor overactivity (NDO). Treatment options for NDO have historically been very limited or invasive, including scheduled toileting, catheterization, or surgery. If left untreated, NDO can lead to worsening urinary tract function in early childhood. Currently, treatment options for children with NDO are limited. The approval and market launch of Myrbetriq tablets and Myrbetriq granules will expand the therapeutic options available for these children, offering a favorable balance of efficacy and tolerability.
Currently, Myrbetriq tablets (mirabegron, extended-release tablets) are marketed in the United States. Myrbetriq granules (mirabegron for oral suspension) were developed to facilitate administration in young children with neurogenic detrusor overactivity (NDO) or those with swallowing difficulties, and are scheduled to be launched in the United States by the end of 2021.
Myrbetriq tablets were initially approved in the United States in 2012 for the treatment of adult patients with overactive bladder (OAB) characterized by symptoms of urge urinary incontinence, urgency, and frequency. This prescription medication can be used as monotherapy or in combination with solifenacin succinate. Since its market launch, nearly 18 million adult patients with urological conditions worldwide have received treatment with Myrbetriq.
Neurogenic Detrusor Overactivity (NDO) is a neurogenic bladder dysfunction caused by nerve damage. Children with NDO may experience involuntary bladder contractions, leading to symptoms of urinary urgency, frequency, and incontinence. Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.
NDO (Image source: compactcath.com)
The approval of Myrbetriq tablets and Myrbetriq granules for the treatment of neurogenic detrusor overactivity (NDO) was based on the results of a pivotal Phase 3 clinical study (NCT02751931). This study evaluated the efficacy, safety, tolerability, and pharmacokinetics of mirabegron in pediatric and adolescent patients (aged 3 to <18 years) with NDO who were managed with clean intermittent catheterization.
The results showed that after 24 weeks of treatment, patients demonstrated improvements in maximum bladder capacity, the number of detrusor (bladder wall muscle) contractions, the urine volume prior to the first detrusor (bladder wall muscle) contraction, and the daily frequency of urinary leakage.
Salim Mujais, M.D., Senior Vice President and Therapeutic Area Head at Astellas, stated, “With this latest approval, Astellas is introducing a new treatment option for children affected by neurogenic detrusor overactivity (NDO), a particularly vulnerable patient population whose needs are difficult to meet. This approval marks a significant milestone for patients suffering from this rare but serious bladder condition.” (Bioon.com)