Novartis’ Zelnorm fails to find approval

The European Medicines Evaluation Agency review committee has recommended that Zelnorm does not receive approval.

News of the advice follows on from an appeal undertaken by Novartis, which manufactures the drug, after the Committee for Medicinal Products for Human Use (CHMP) recommended to the European Commission that Zelnorm should not be approved.

Dr James Shannon, head of global pharma development at Novartis, said he was “disappointed” about the decision.

“The extensive clinical trials programme and its use by nearly four million patients in more than 30 countries ? clearly demonstrate the clinical benefits, efficacy and safety of Zelnorm,” he said.

Zelnorm is used for the treatment of irritable bowel syndrome with constipation (IBS-C) in women who suffer from the condition.

The drug has already been approved for use in over 56 countries ? including Switzerland, Australia and the US.

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