Trial Profile

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 06 Nov 2019

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At a glance

23 Sep 2019 Results of pooled analysis of three trials (PARADIGM 2, PARADIGM 4 and PARADIGM 5) assessing plasma PEG concentrations in children, adolescents and adults undergoing once-weekly intravenous prophylactic treatment with N9-GP for up to 6.5 years, published in the BioDrugs.
06 Jun 2017 According to a media release, the company expects to launch Refixia in the first Europe
06 Jun 2017 According to a Novo Nordisk media release, based on the results from the paradigm clinical trial programme (see profiles 243891, 243935, 243947,243961 and 244049) and the positive opinion provided on 24 March 2017 by the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorisation for Refixia for the treatment of adolescents and adults with haemophilia B.

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