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March 29, 2021/bioon.
com" target="_blank">/--The Japanese pharmaceutical company Astellas recently announced that the US Food and Drug Administration (FDA) has approved: (1) Myrbetriq tablets (mirabegron, Mirabegron, sustained-release tablets) for treatment Children with neurogenic detrusor hyperactivity (NDO) aged ≥3 years and weighing ≥35 kg; (2) Myrbetriq granules (mirabegron, Mirabegron, oral suspension), used to treat age ≥ A 3-year-old NDO pediatric patient.
In addition, the bioon.
com/fda/" target="_blank">FDA also approved Myrbetriq's pediatric exclusivity, thereby extending its market exclusivity by 6 months.
bioon.com" target="_blank">/--The Japanese pharmaceutical company Astellas recently announced that the US Food and Drug Administration (FDA) has approved: (1) Myrbetriq tablets (mirabegron, Mirabegron, sustained-release tablets) for treatment Children with neurogenic detrusor hyperactivity (NDO) aged ≥3 years and weighing ≥35 kg; (2) Myrbetriq granules (mirabegron, Mirabegron, oral suspension), used to treat age ≥ A 3-year-old NDO pediatric patient.
In addition, the bioon.
com/fda/" target="_blank">FDA also approved Myrbetriq's pediatric exclusivity, thereby extending its market exclusivity by 6 months.
com" target="_blank">bioon.
com/fda/" target="_blank">FDA
Myrbetriq tablets and Myrbetriq granules have been approved through the priority review process, and are currently the first-in-class products approved by the bioon.
com/fda/" target="_blank">FDA for the treatment of children with NDO.
Treatment options for NDO have been very limited or invasive, including regular toileting, urination, or surgery.
Without treatment, NDO can cause deterioration of urinary tract function in early childhood.
Currently, treatment options for children with NDO are limited.
The approval of Myrbetriq tablets and Myrbetriq granules will expand the treatment options available for these children and provide a good balance of efficacy and tolerability.
bioon.com/fda/" target="_blank">FDA for the treatment of children with NDO.
Treatment options for NDO have been very limited or invasive, including regular toileting, urination, or surgery.
Without treatment, NDO can cause deterioration of urinary tract function in early childhood.
Currently, treatment options for children with NDO are limited.
The approval of Myrbetriq tablets and Myrbetriq granules will expand the treatment options available for these children and provide a good balance of efficacy and tolerability.
com/fda/" target="_blank">FDA
Currently, Myrbetriq tablets (Mirabegron, sustained-release tablets) have been marketed in the United States.
Myrbetriq granules (mirabegron, oral suspension) were developed for the convenience of young NDO children or NDO children who have difficulty swallowing, and will be marketed in the United States at the end of 2021.
Myrbetriq granules (mirabegron, oral suspension) were developed for the convenience of young NDO children or NDO children who have difficulty swallowing, and will be marketed in the United States at the end of 2021.
Myrbetriq tablets were originally approved in the United States in 2012 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge incontinence, urgency, and frequent urination.
This medicine is a prescription medicine that can be used alone or in combination with solifenacin succinate.
Since its launch, nearly 18 million adult patients with urinary system diseases have received Myrbetriq treatment worldwide.
This medicine is a prescription medicine that can be used alone or in combination with solifenacin succinate.
Since its launch, nearly 18 million adult patients with urinary system diseases have received Myrbetriq treatment worldwide.
Neurogenic detrusor hyperactivity (NDO) is a neurogenic bladder dysfunction caused by nerve damage.
Children with NDO may experience involuntary bladder contractions, which can cause symptoms of urinary urgency, frequent urination, and urinary incontinence.
Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.
Children with NDO may experience involuntary bladder contractions, which can cause symptoms of urinary urgency, frequent urination, and urinary incontinence.
Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.
NDO (Image source: compactcath.
com)
com)
The approval of Myrbetriq tablets and Myrbetriq granules for NDO indications is based on the results of a key phase 3 clinical study (NCT02751931).
The study was conducted in NDO children and adolescents (aged 3 to 18 years old) who used clean intermittent catheterization to evaluate the efficacy, safety, tolerability, and pharmacokinetics of mirabegron.
The study was conducted in NDO children and adolescents (aged 3 to 18 years old) who used clean intermittent catheterization to evaluate the efficacy, safety, tolerability, and pharmacokinetics of mirabegron.
The results showed that after 24 weeks of treatment, the patient’s maximum bladder capacity, the number of detrusor (bladder wall muscle) contractions, the volume of urine before the first detrusor (bladder wall muscle) contraction, and the number of daily leaks all improved .
Salim Mujais, MD, Senior Vice President and Director of Medical Specialties of Astellas said: "With this latest approval, Astellas has proposed a new treatment plan for children affected by NDO.
NDO is a special The needs of the vulnerable patient population are difficult to meet.
For patients with this rare but serious bladder disease, this approval marks an important milestone.
" ()
NDO is a special The needs of the vulnerable patient population are difficult to meet.
For patients with this rare but serious bladder disease, this approval marks an important milestone.
" ()
Original Source: Astellas Garners New Indication & New Product Formulation Approvals From US bioon.
com/fda/" target="_blank">FDA for Children with Neurogenic Detrusor Overactivity (NDO) Myrbetriq (Mirabegron Extended-Release Tablets) app roved for Pediatric Patients with NDO Aged Three Years and Older
bioon. com/fda/" target="_blank">FDA for Children with Neurogenic Detrusor Overactivity (NDO) Myrbetriq (Mirabegron Extended-Release Tablets) app roved for Pediatric Patients with NDO Aged Three Years and Older
com/fda/" target="_blank">FDA app
