Astellas Reports the US FDA's Acceptance of Priority Review for its NDO Therapy
Shots:
- The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron- tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28- 2021
- The NDA & sNDA is based on P-III study assessing efficacy- safety- tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
- In 2012- Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence- urgency and urinary frequency
Ref: PRNewswire | Image: Astellas
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