Positive opinion from CHMP for Veloxis’ Envarsus

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has today adopted a positive opinion recommending marketing authorization for Denmark-based Veloxis Pharmaceuticals’ (OMX: VELO) Envarsus((once-daily tacrolimus; formerly LCP-Tacro)) for the prevention of organ rejection in adult transplant patients in the European Union.

The positive opinion is for both kidney and liver transplant recipients and includes both the de novo transplant and "switch" settings, as well as for treatment of rejection episodes resistant to treatment with other immunosuppressive products in adult patients. The CHMP's decision will be referred to the European Commission and if approved by the EC, Veloxis will receive marketing authorization for Envarsus in all member states of the EU. The EC is expected to render a final decision within three months of the opinion.

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