Nycomed applies for EU approval of Revestive

Nycomed is applying to the European Medicines Agency for approval of Revestive, its new treatment for short bowel syndrome.

A marketing authorisation application has been submitted to the healthcare regulator for the once-daily subcutaneous treatment, which has been granted orphan drug designation based on the rarity of short bowel syndrome cases in Europe.

The submission has been made on the basis of positive data from a recent placebo-controlled clinical trial, showing that the drug can help patients to minimise their reliance on parenteral support.

Revestive was originally developed by NPS Pharmaceuticals, which granted Nycomed rights to commercialise the drug outside North America in 2007.

Anders Ullman, executive vice-president research and development at Nycomed, said: "This submission clearly demonstrates Nycomed's dedicated efforts and strong commitment to bring new and innovative treatments to patients and caregivers addressing a high unmet medical need."

Earlier this month, the company published a report showing that it has benefited from an increased presence in emerging markets during the last year.