FDA clears new indication, formulation for Astellas’ Myrbetriq

The Food and Drug Administration approved a new indication for Astellas’ Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension). The product now is indicated to treat neurogenic detrusor overactivity, or NDO, a bladder dysfunction related to neurological impairment, in children ages 3 years and older. Myrbetriq also is indicated for overactive bladder in adult patients.

"Today's action is a positive step for the treatment of NDO in young patients," said Christine Nguyen, director of the FDA's Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. "Mirabegron, the active ingredient in Myrbetriq and Myrbetriq Granules, works by a different mechanism of action from the currently approved treatments, providing a new treatment option for these young patients. We remain committed to facilitating the development and approval of safe and effective therapies for pediatric NDO patients."

"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, senior vice president and head of Astellas Medical Specialties. "This approval marks a significant milestone for patients living with this rare but serious bladder condition that can cause unwanted accidents."

"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."

Myrbetriq tablets are currently available. Myrbetriq Granules 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 by the end of 2021.