The European Commission has granted marketing authorization to Almirall’s Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults . This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.
Constella is an oral, once-daily medication. Linaclotide, the active ingredient in Constella, is a guanylate cyclase-C agonist (GCCA) with visceral analgesic and secretory activities, as stated in the product label for European use. In non-clinical studies, linaclotide has been shown to reduce visceral pain by decreasing pain-fiber activity and to accelerate gastrointestinal transit by increasing intestinal fluid secretion. Linaclotide acts locally in the intestine with minimal systemic exposure.
Linaclotide was developed by Ironwood Pharmaceuticals. In April 2009, Almirall signed a license agreement with Ironwood Pharmaceuticals, under which Almirall holds exclusive marketing rights for linaclotide in all E.U. member states, plus Russia, the CIS (Commonwealth of Independent States of the former USSR), Switzerland, Norway and Turkey, as well as other countries in Europe.
“Despite affecting more than 10% of the population in the E.U. there are few effective treatment options for IBS,” said Jan Tack, head of clinic in gastroenterology, Almirall. “Approximately one-third of IBS patients suffer from the IBS-C form of the disease and the approval of Constella provides physicians with an innovative medication, for improving the lives of patients whose quality of life is impaired.”
Eduardo Sanchiz, CEO of Almirallm, said, “Almirall is delighted with the approval of Constella, the first prescription medicine approved by the European Commission for the treatment of IBS-C in adults. This new medicine has the potential to improve some of the hallmark symptoms of IBS-C patients who up until now have had few treatment options. Furthermore the approval of Constella is an important growth opportunity for Almirall and will strengthen our gastrointestinal franchise.”
Almirall expects to begin launching Constella in Europe in the first half of 2013.