GlaxoSmithKline seeking marketing authorisation for Arzerra
6 February 2009 00:00 in Pharmaceutical Company Product News
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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