Vonicog to treat bleeding disorder in EUDecember 13, 2018
The European Commission (EC) has granted Marketing Authorization for vonicogalfa (Veyvondi) for the treatment of bleeding events and treatment of surgical bleeding in adults with von Willebrand disease (VWD).
Vonicog alfa is the first and only recombinant von Willebrand Factor (rVWF) treatment in the EU for VWD that specifically addresses the primary deficiency, Shire Plc said.
EC has reviewed the outcomes from three clinical trials of a total80 patients with VWD exposed to vonicogalfa. These include a Phase 1 multicentre, controlled, randomized, single-blind, dose-escalation study of the safety, tolerability, and pharmacokinectics(PK) of rVWF:rFVIII in subjects 18 to 60 years of age with severe VWD.
VWD is caused by a deficiency or dysfunction of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.
Only a minor proportion of affected individuals have the severe form of the disease and are in need of VWF replacement.
Vonicog alfa is indicated in adults with VWD, when desmopressin (DDAVP) treatment alone is ineffective.