Regulatory Focus™ > News Articles > Germany’s IQWiG Declines to Recommend Linaclotide for Irritable Bowel Syndrome

Germany’s IQWiG Declines to Recommend Linaclotide for Irritable Bowel Syndrome

Posted 08 August 2013 | By

Linaclotide, more commonly known by its trade name, Constella, has been approved in Germany since November 2012 for the treatment of moderate to severe irritable bowel syndrome (IBS) with constipation in adults. However, following an early assessment of the drug's benefits , the German Institute for Quality and Efficiency in Health Care (IQWiG) concluded that there was no proof of benefits over and above those of the current standard therapy because the appropriate comparator therapy was not implemented adequately in any of the three studies cited by the drug manufacturer.

Moreover, the treatment phases in two of these studies were too short for a drug that is approved for maintenance treatment, regulators said.

Another problem cited by IQWiG was that two of the three studies only lasted 12 weeks and were therefore too short to assess a drug that is meant and approved for long-term continuous treatment. IBS typically has a fluctuating course, so that treatment and observation should last at least 24 weeks.

In IBS, the intestinal muscles move the food mass too slowly, resulting in over-absorption of water which can lead to constipation, abdominal pain, bloating and cramping. Linaclotide aims to improve digestion and thus relieve the symptoms. The comparator therapy involves dietary changes under medical consultation and symptomatic treatment.

Linaclotide was developed by Ironwood Pharmaceuticals, based in Cambridge, Massachusetts, and was approved in the US for the treatment of chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults on 30 August 2012.

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Tags: IBS, IQWiG, Germany

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