Myrbetriq® (Mirabegron Extended-Release Tablets) Approved for Pediatric Patients with NDO Aged Three Years and Older Weighing
35 kg or More
Myrbetriq® Granules (Mirabegron for Extended-Release Oral Suspension) Approved for Pediatric Patients with NDO Aged Three Years and Older
TOKYO, March 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules (mirabegron for extended-release oral suspension) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. The FDA also granted pediatric exclusivity for Myrbetriq, resulting in an additional six month period of market exclusivity.
Myrbetriq and Myrbetriq Granules are first-in-class to now be FDA-approved for children with NDO. Treatment options for NDO have been limited or invasive, including scheduled toileting, catheterization, or surgery.1 If left untreated, NDO can lead to the deterioration of urinary tract function at an early age.2
“With this latest approval, Astellas is bringing forward a new treatment option for children impacted by NDO, an especially vulnerable patient population with high unmet need,” said Salim Mujais, M.D., senior vice president and head, Medical Specialties, Astellas. “This approval marks a significant milestone for patients living with this rare but serious bladder condition that can cause unwanted accidents.”3
NDO is a type of bladder dysfunction caused by nerve damage and is marked by uncontrolled bladder contractions that can lead to symptoms of urinary frequency, urgency and incontinence.1 Eighty-five percent of children with NDO have spina bifida, a congenital spinal cord defect.3
Myrbetriq tablets (mirabegron extended-release tablets) are currently available in the U.S.
Myrbetriq Granules (mirabegron for extended-release oral suspension) were developed for ease of administration in younger children with NDO, or children with NDO who may have difficulty swallowing tablets, and will be available in the U.S. by the end of 2021.
“Astellas is a long-time leader in the field of urologic health and is committed to advancing the treatment of bladder conditions that adversely impact the lives of patients,” continued Mujais. “Since its initial approval nine years ago, Myrbetriq has been used to treat nearly 18 million adult patients worldwide with urological conditions.”4
The approval for the NDO indication was based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents (aged 3 to <18 years) with NDO and using clean intermittent catheterization (ClinicalTrials.gov Identifier: NCT02751931).
Astellas has already reflected the impact from this FDA approval in its financial forecast for the current fiscal year, ending March 31, 2021.
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