Linaclotide is a pan-European first-in-class opportunity (licensed from Ironwood) in an indication IBS-C5 with high unmet need in which no specific treatments have been approved by the EMA6. Two pivotal phase III studies were positively completed during 2010 with positive results. Based on Scientific Advice from the EMA6, Almirall will utilize the IBS-C5 Phase III linaclotide clinical studies curried out in the US as a basis for a Market Authorisation Application. No additional EU Phase III clinical studies are contemplated. Almirall plans to file linaclotide in Europe in the second half of 2011.
24 March 2011 EMA/PDCO/213115/2011 Monthly report Paediatric Committee (PDCO) 16-18 March 2011
The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for the following medicines: Linaclotide, from Almirall S.A., in the therapeutic area of gastroenterology
A PIP sets out a programme for the development of a medicine in the paediatric population. The PIP aims to generate the necessary quality, safety and efficacy data through studies to support the authorisation of the medicine for use in children of all ages. These data have to be submitted to the European Medicines Agency, or national competent authorities, as part of an application for a marketing authorisation for a new medicine, or for one covered by a patent. In some cases, a PIP may include a waiver of the studies in one or more paediatric subsets, or a deferral.
The next meeting of the PDCO will be held on 18-20 April 2011.
"We were pleased to announce, along with our partner Ironwood Pharmaceuticals, Inc., positive top-line results from a Phase III clinical trial assessing the efficacy and safety of linaclotide for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). With the successful completion of this clinical trial we now have two positive Phase III IBS-C trials and two positive Phase III chronic constipation (CC) trials. We look forward to filing the linaclotide NDA for both indications in the third quarter of 2011"