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Home Industry News GlaxoSmithKline seeking marketing authorisation for Arzerra

GlaxoSmithKline seeking marketing authorisation for Arzerra

6th February 2009

GlaxoSmithKline (GSK) and Genmab are seeking European marketing authorisation for Arzerra, according to the former.

Used for the treatment of chronic lymphocytic leukaemia, the product targets a binding site on the CD30 molecule of B-cells.

The application to the European Union follows a submission to the US Food and Drug Administration on January 30th this year.

Carlo Russo, senior vice-president of GSK’s BioPharm subsidiary, said the product is a “new generation of monoclonal antibody”.

He went on to note: “We plan additional studies to understand its potential in lymphomas and selected autoimmune diseases.”

Chief executive officer of Genmab Lisa Drakeman went added the collaboration is studying the drug’s efficacy as a treatment for other conditions.

Last month, GSK’s Synflorix therapy received positive opinion in Europe.

The paediatric vaccine is set to be used as a protective treatment against invasive pneumococcal disease and middle ear infections, which are caused by Streptococcus pneumoniae.

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