Shire Pharmaceuticals seeks approval for Mesavance

Shire Pharmaceuticals has filed a US new drug application (NDA) for its Mesavance treatment.

The drug, which is designed to treat mild-to-moderate ulcerative colitis, is currently being studied for its effectiveness in inducing endoscopic and clinical remission in patients.

If the drug is approved, Mesavance would become the first once-daily treatment for mild and moderate forms of the disease. Shire will apply for a marketing authorisation application with the European Medicines Agency (EMEA).

“The timely filing of our Mesavance NDA represents the fourth new product submission in 2005 for Shire and our partners,” said Shire’s chief executive Matthew Emmens.

“We are proud of that achievement and we look forward to offering the advantages of once-daily MESAVANCE to patients suffering from ulcerative colitis,” he added.

Mesavance is the result of an agreement between Shire and Italian drug maker Giuliani, who has licensed Shire to develop and market the drug in the US, Canada, the Pacific Rim and the rest of Europe excluding Italy.

The treatment works by releasing its active component mesalamine over an extended period of time.

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