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EMEA approval sought for vorinostat


Merck has filed a marketing authorisation application with the European Medicines Agency (EMEA) for vorinostat for the treatment of advanced, refractory cutaneous T-cell lymphoma (CTCL) in the European Union (EU).

If the application is approved, the company will be able to market the drug in all of the 27 countries which make up the EU, as well as Iceland and Norway.

The company said that it is also filing additional international
applications in order to seek authorisation to market the drug in other countries.

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Stephen Friend, executive vice president of oncology at Merck, said: “The filing of a marketing application for vorinostat in Europe reflects our ongoing commitment to bring novel anticancer agents to market worldwide.

“Vorinostat is one of several investigational therapies that represent an important part of the growing oncology franchise, offering the potential to become an important therapeutic option for CTCL as well a variety of cancer tumour types.”

The tablet is sold under the trade name Zolinza (vorinostat) in the US, after the Food and Drug Administration approved it in October 2006 for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies.

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