Myrbetriq accepted for FDA priority review for NDO

The US. Food and Drug Administration has accepted for priority review the New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2021, says the drug’s developer, Japanese drug major Astellas Pharma (TYO: 4503), whose shares edged up 1% to 1,592 yen on the news today.

“These regulatory submissions mark an important step toward addressing the unmet treatment needs for children with neurogenic detrusor overactivity. Treatment options for children with neurogenic detrusor overactivity are limited,” said Dr Salim Mujais, senior vice president and head, Medical Specialties, Astellas, adding: “Mirabegron has the potential to expand the repertoire of treatments available for these children, offering a favorable balance of efficacy and tolerability.”