January meeting highlights from EMA/CHMP

30 January 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorization at its January 2016 meeting, two of which – for Empliciti and Coagadex – will becovered in separate stories.

The CHMP recommended Swiss biotech firm Actelion’s (SIX: ATLN) Uptravi (selexipag) for the treatment of pulmonary arterial hypertension. Uptravi has an orphan designation.

Uptravi is indicated for the long term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE 5) inhibitor, or as monotherapy in patients who are not candidates for these therapies

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