Extensions of indications recommended by EMA/CHMP for three drugs

25 February 2017

As well as four new drug approvals, at its February meeting the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended broader use of three already marketed products.

The Committee recommended extensions of indications for Janssen’s Darzalex, (daratumumab), Novartis’ (NOVN: VX) Mekinist + Tafinlar (trametinib + dabrafenib), and Gilead Sciences’ (Nasdaq: GILD) Truvada emtricitabine/tenofovir disoproxil).

The recommendation is for the use of Darzalex in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The variation to the Marketing Authorization for this indication was submitted to the EMA in August 2016. In August 2012, Dpenmark-based biotech firm Genmab (OMX: GEN) granted Janssen Biotech, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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