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Takeda’s Revestive becomes first approved drug in Europe for short bowel syndrome

Can reduce dependency on intravenous feeding

Takeda's Revestive has become the first drug available in Europe for the treatment of short bowel syndrome, a condition caused by the surgical removal of a patient's small intestine due to Crohn's disease, ischaemia or another illness.

The European Commission (EC) approved Revestive (teduglutide) as a way to reduce dependence on an intravenous method of feeding (parenteral nutrition), which has been associated with serious complications, such as infections, blood clots and liver damage.

Patients on parenteral nutrition also often experience a poor quality of life with difficulty sleeping, frequent urination and loss of independence, said Takeda.

“Short bowel syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life,” said Professor Palle Bekker Jeppese from the department of medical gastroenterology, Rigshospitalet, University Hospital of Copenhagen in Denmark.

“Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium.”

The drug was originally developed by NPS Pharmaceutical, but the European marketing authorisation will be held by Takeda subsidiary Nycomed Danmark after the company was granted the rights to develop and commercialise teduglutide outside the US, Canada and Mexico and Israel in 2007.

NPS retains all rights to teduglutide in North America and submitted it for approval to the US Food and Drug Administration (FDA) in November 2011 under the brand name Gattex.

The drug works by replicating a naturally occurring protein that is involved in the rehabilitation of the intestinal lining, and has demonstrated it can reduce the need for parenteral nutrition.

This includes data from the STEPS phase III safety and efficacy trial, which involved 43 patients taking Revestive and 43 taking placebo for up to 24 weeks.

The proportion of patients treated with Revestive who achieved a 20 per cent to 100 per cent reduction of parenteral nutrition at week 20 and 24 was 63 per cent compared to only 30 per cent of those participants taking placebo.

Overall, treatment with Revestive resulted in a 4.4 litre perweek reduction in parenteral nutrition requirements versus 2.3 litre per week for placebo at 24 weeks.

6th September 2012

From: Sales

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