Keywords: GlaxoSmithKline, Zunrisa, EMEA, MA withdrawal

GlaxoSmithKline withdraws European MA for nausea drug Zunrisa

Article | 14 October 2009

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UK drug giant GlaxoSmithKline has told the European Medicines Agency (EMEA) that it is withdrawing its application for a centralized marketing authorization for Zunrisa (casopitant mesilate), 50mg and 150mg film coated tablets, in what it described as “a difficult decision.” Zunrisa was expected to be used in the prevention of post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting.

The MA application for Zunrisa was submitted to the Agency on July 2, 2008. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

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In its official letter, the company stated that the withdrawal of the application was based on the company's assessment that further safety data would be required to support the registration of casopitant on a worldwide basis and that it would take considerable time to produce these data. The company further stated that, as a consequence, all ongoing applications for authorization are being withdrawn.

Zunrisa, also trade named Rezonic, is a novel, investigational NK-1 receptor antagonist. NK-1 receptor antagonists like casopitant block substance P from binding to receptors within the brain and have the potential to add benefit beyond standard 5-HT3 inhibitors. Earlier clinical data on the drug showed a significant reduction in the number of patients experiencing chemotherapy-induced nausea and vomiting.

More information about Zunrisa and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document, according to the EMEA. This document, together with the withdrawal letter from the company, will be published on the Agency's web site after the next CHMP meeting of October 19-22, 2009.