IQWiG finds no added benefit proven for Constella in IBS

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Constella (linaclotide), from Spain’s largest drugmaker Almirall (ALM: MC) and partner USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD) offered no added benefit over the current standard therapy for the treatment of adults with moderate to severe irritable bowel syndrome (IBS) with constipation.

Constella is the first and only product approved in the European Union for the treatment of IBS-C in adults, Almirall has previously said, and has been demonstrated in clinical trials to improve abdominal pain – one of the hallmark symptoms of IBS-C, as well as to improve constipation-related symptoms.

The IQWiG said that an added benefit is not proven because the dossier did not contain any relevant studies: 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.