Therapy Areas: Central Nervous System
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
10 June 2022 - - France-based pharmaceutical company Ipsen's (Euronext: IPN) (OTC: IPSEY) Dysport (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who are regularly performing clean intermittent catheterization, the company said.

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.

Dysport is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which has previously shown clinically meaningful benefit in the symptomatic treatment of focal spasticity and cervical dystonia.

Dysport was assessed in CONTENT, a large, international, Phase III clinical program. The CONTENT1 and CONTENT2 Phase III trials included 485 patients living with NDO and UI who were regularly undergoing CIC and inadequately managed by oral therapy.

Patients recorded the number of UI episodes they experienced per day over a 7-day period in an eDiary at baseline and at weeks 2, 6, and 12, and every 12 weeks thereafter. The volume per void during a 24-hour period was also recorded in the eDiary.

Neurogenic detrusor overactivity incontinence is a chronic condition caused by lesions of the central nervous system that result in urinary incontinence.

Up to 99% of patients living with MS and up to 84% of patients living with SCI suffer from NDO and it can cause a substantial impairment to quality of life, social isolation, and embarrassment.

Dysport (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions.

It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in more than 90 countries, more than 30 years of clinical experience and 6 m treatment years of patient experience.

The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics for Dysport (300 units) Powder and Dysport (500 units) Powder, and the US Prescribing Information (PI).

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience.

With Specialty Care sales of over EUR 2.6bn in FY 2021, Ipsen sells medicines in over 100 countries.

Ipsen has around 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the US through a Sponsored Level I American Depositary Receipt program (OTC: IPSEY).


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