Spanish pharma company Almirall has moved a step closer to securing EU approval for its irritable bowel syndrome treatment Constella, which remains on track to become the first drug specifically approved for the condition.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that Constella (linaclotide) be authorised for the treatment of adult IBS patients with constipation, a common form of the disease.
The positive opinion for Constella comes after the drug was approved in the US, where it will be sold by originator Ironwood Pharmaceuticals and co-marketing partner Forest Laboratories when it launches in the fourth quarter.
The US indication for the drug is a little broader, including IBS with constipation as well as chronic idiopathic constipation.
At the time of US approval analysts predicted that Constella could become a future blockbuster given the frequency of IBS and the lack of available treatments, particularly for the pain associated with the condition.
Peak sales could reach $2bn or more by the end of the decade they noted, although sales are likely to grow slowly as doctors gradually become comfortable with using the drug.
The EMA mentioned that the active ingredient in Constella is a first-in-class peptide that works by increasing the secretion of fluid in the intestine and accelerates gastrointestinal motility.
"Despite affecting up to 20 per cent of the Western population, no medicines have been authorised in the EU specifically for the treatment of IBS," said the EMA.
Almirall estimates that around 10 to 15 per cent of the European population of around 740 million people suffer from IBS. Around a third of patients with IBS have a form associated with chronic constipation.
The Spanish drugmaker is looking forward to a healthy spell of revenue growth in the next few years after winning approval in the EU and US for chronic obstructive pulmonary disease (COPD) treatment Eklira/Tudorza (aclidinium bromide).