Novo Nordisk Pulls Unlucky NovoSeven Application In EU
This article was originally published in The Pink Sheet Daily
Executive Summary
Novo Nordisk will resubmit the application for its factor VIIa product for a supplemental intracerebral hemorrhage indication.
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Novo Nordisk will resubmit a marketing authorization application for a new indication for its human recombinant factor VIIa NovoSeven after completing an ongoing clinical study. The European Medicines Agency announced April 6 that Novo Nordisk has withdrawn the MAA to extend NovoSeven's indication "to include the treatment of acute intracerebral hemorrhage in adults for limiting hemorrhage growth and improving clinical outcomes." After reviewing NovoSeven's dossier for the ICH indication, EMEA's Committee for Medicinal Products for Human Use requested additional safety and efficacy data, EMEA said. Novo Nordisk submitted the dossier in October 2005. NovoSeven is approved in the EU for treatment of bleeding episodes and prevention of bleeding during surgery or invasive procedures in patients with blood-clotting disorders. The drug is currently in Phase III studies for an ICH indication in the U.S. Novo Nordisk is also looking to expand NovoSeven's use to blunt trauma in the U.S. and the EU. The blunt trauma MAA is pending at EMEA; the U.S. indication was slowed by a clinical hold on the corresponding trial. FDA lifted the hold in 2004 and Phase III trials are now ongoing (1 (Also see "Novo Nordisk's NovoSeven To Enter Clinic For Trauma Bleeding" - Pink Sheet, 13 Aug, 2004.)). Novo Nordisk also has several Phase II trials in progress for additional indications for NovoSeven, including cardiac surgery and spinal surgery. -Kathleen Michael |