product approval introduction

Ipsen Receives Positive Opinion In Europe for Dysport® In the Management of Urinary Incontinence In Adults With Neurogenic Detrusor Overactivity Due to Multiple Sclerosis or Spinal Cord Injury

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Dysport® (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC).  This positive opinion for Dysport® now permits individual European country Health Authorities to grant national approvals, according to their country regulations.  In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union. Read more.

Source: Globe Newswire, June 9, 2022

spine anatomy

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