Almirall receives CHMP backing for Constella approval
25 September 2012 11:12 in Pharmaceutical Company Product News
Almirall has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval of Constella, a treatment for irritable bowel syndrome with constipation (IBS-C).
The committee has endorsed the linaclotide treatment for marketing approval for the symptomatic treatment of moderate to severe IBS-C among adult patients, based on positive safety and efficacy data from a pair of phase III trials.
Constella is being co-commercialised by Almirall and Ironwood Pharmaceuticals, with the latter company having discovered the compound and the former holding exclusive European marketing rights.
Clinical studies of the drug involved around 1,600 patients and demonstrated its effectiveness in treating a disease for which there are very few available therapies.
Bertil Lindmark, chief scientific officer at Almirall, said: "We are very pleased at Almirall with this first IBS-C treatment recommended for approval by CHMP and are confident in linaclotide's benefits."
Earlier this month, the company announced the launch of Eklira Genuair, a new maintenance therapy for chronic obstructive pulmonary disease for adult patients.
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