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NicOx withdraws marketing authorisation application


A French pharmaceutical company has announced its decision to withdraw the Marketing Authorisation Application (MAA) for its osteoarthritis candidate naproxcinod from the centralised procedure in Europe.

NicOx submitted the naproxcinod MAA to the European Medicines Agency (EMA) in December 2009. The decision to withdraw the European MAA was made following the feedback at the April meeting of the Committee for Medicinal Products for Human Use (CHMP) that the CHMP would not adopt a formal positive opinion on the basis of the submitted information.

NicOx has notified the EMA of its decision to withdraw the naproxcinod MAA, based on the CHMP considering that the data provided did not allow them to conclude on a positive benefit-risk balance. NicOx is now evaluating its options for the potential further development of naproxcinod in Europe, together with its advisors and with Grupo Ferrer Internacional S.A. which has an option for rights to naproxcinod in certain European countries.

NicOx submitted a New Drug Application (NDA) for naproxcinod to the U.S. Food and Drug Administration (FDA) and received a Complete Response Letter in July 2010 stating that the FDA did not approve naproxcinod. NicOx has decided to appeal the FDA decision under the FDA’s Formal Dispute Resolution process and is currently finalising the submission of the supporting information for the appeal.

NicOx is developing a number of nitric oxide-donating New Molecular Entities (NMEs), both internally and with its partners Bausch + Lomb, Merck (known as MSD outside the United States and Canada) and Ferrer. The Company had €107.3 million in cash and cash equivalents as of December 2010 and is focused on a number of strategic priorities, including actively seeking appropriate M&A opportunities and new alliances on existing programs as well as targeting internal research resources on the most promising programmes.

As per the EMA’s guidelines, both a ‘Question and Answer’ document summarising the CHMP evaluation and the public Assessment Report will be made available on the agency’s website at a later date.


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