NN7128 / Novo Nordisk - LARVOL DELTA

40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics, and preliminary efficacy in hemophilia patients with inhibitors (J Thromb Haemost) - P2, N=23; NCT00951405; Sponsor: Novo Nordisk; PMID: 23578227; "The annualized bleeding rate (ABR) decreased in the treatment period vs. the observation period at all N7-GP dose levels. However, a dose-response relationship in the reduction could not be established in the N7-GP dose range evaluated. The ABR was also reduced at two dose levels during the last part of the observation period, and increased notably in the follow-up period irrespective of previous N7-GP dose."

P2 data • Hemophilia

Interim financial report for the period 1 January 2011 to 30 September 2011 (Novo Nordisk) - Longer-acting recombinant factor VIIa derivative, NN-7128/NN-7129, discontinued following further analysis of the P2 results for the longer-acting recombinant factor VIIa derivative, N7-GP; Novo Nordisk has decided to discontinue development of this compound for prophylactic treatment in hemophilia pts with inhibitors

Product discontinuation • Hemophilia

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