Janssen receives CHMP backing for subcutaneous Velcade
28 June 2012 11:18 in Pharmaceutical Company Product News
Janssen has been granted a positive recommendation from Europe's Committee for Medical Products for Human Use (CHMP) for its subcutaneous version of Velcade.
The European Medicines Agency (EMA) committee has endorsed the potential benefits of under-the-skin administration of the multiple myeloma treatment based on positive data from clinical studies.
Phase III trial results showed that subcutaneous Velcade can offer similar efficacy to the intravenous formulation, while providing greater convenience and reducing the frequency and seriousness of side effects.
A final decision from the European Commission is expected in mid-2012 and, if it is positive, could offer a new therapy option for European patients.
Jane Griffiths, chairman for Janssen in the EMEA region, said: "If approved, subcutaneous administration will be the administration of choice versus intravenous, combining better tolerability with maintained high efficacy."
Earlier this week, Janssen submitted a new treatment for type 2 diabetes for EMA approval, with encouraging phase III clinical data supporting the application.
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