Astellas Wins Expanded Label to Include Pediatric Use for Oral Solifenacin in the EU

Tokyo-based Astellas Pharma (TYO: 4503) has been awarded EU approval for its neurogenic detrusor overactivity (NDO) therapy solifenacin succinate in oral suspension form. The drug is indicated for children aged 2 to 18 years. NDO is a bladder dysfunction in which increased storage pressure can put the upper urinary tract at risk of deterioration. Commonly observed in patients with conditions such as multiple sclerosis and spinal cord injury, it causes urinary incontinence in approximately 50% of MS patients. Read more.

Source: The Pharma Letter, March 9, 2018

U.S. FDA Accepts for Review Astellas sNDA for Mirabegron

Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.

Source: Gurufocus.com, September 12, 2017

Astellas Submits Supplemental New Drug Application for Mirabegron

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq^® and VESIcare^®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.

Source: PRNewswire, June 29, 2017