Date: 2012-01-24
Type of information:
phase: post-marketing study
Announcement: results
Company: Pharming (The Netherlands)
Product: Ruconest® (Rhucin® in non-European territories - conestat alfa)
Action
mechanism: Ruconest® is a recombinant v ersion of the human protein C1 inhibitor (C1INH). It is produced through Pharming’s proprietary technology in milk of transgenic rabbits.
Disease: acute angioedema attacks in patients with Hereditary Angioedema (HAE)
Therapeutic area: Rare diseases - Genetic diseases
Country:
Trial details:
Latest
news: Pharming Group has announced that recombinant human C1 inhibitor (rhC1INH; Ruconest®) was not observed to have a prothrombotic effect when used to treat acute Hereditary Angioedema (HAE) attacks in a study published by Relan et al in the peer-reviewed journal Biodrugs. These results can be found online and will be published in print on 1 February 2012 in Biodrugs issue 26:1. Thrombotic events have been reported at the recommended dose of plasma-derived C1 inhibitor products following treatment of HAE. To investigate the effect of Ruconest® on blood clotting parameters, blood samples of 25 HAE patients experiencing an angioedema attack included in a randomized clinical tr ial were analyzed for levels of coagulation (clotting) and fibrinolytic (clot dissolution) parameters before and after infusion of saline placebo, Ruconest® 50 U/kg, or Ruconest® 100 U/kg. The findings in this study suggest that HAE patients feature changes in coagulation and fibrinolytic parameters during an HAE attack. Administration of Ruconest® dose-dependently restored the balance in the intrinsic coagulation pathway and resulted in a reduction of thrombin generation. No harmful effect was observed either on other coagulation or fibrinolysis activation parameters.
