The European Medicines Agency last Friday issued a batch of recommendations relating to marketing authorization applications under consideration by the Agency, as well as from its Committee for Medicinal Products for Human Use (CHMP).
First up, the EMA said it recommends authorization of Constella (linaclotide), the first medicine specifically for irritable bowel syndrome. Spain’s largest drugmaker, Almirall (ALM: MC), has exclusive European marketing rights to the drug from USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD).
The Agency is recommending that Constella be authorized for adults with moderate to severe IBS with constipation (IBS-C), a common subtype of the disease. Linaclotide is a new, synthetic 14-amino-acid peptide, which works by increasing the secretion of fluid in the intestine and accelerating the movement of material through the gut.
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