Novo Nordisk's NovoSeven To Enter Clinic For Trauma Bleeding
This article was originally published in The Pink Sheet Daily
Executive Summary
A U.S. clinical trial for a trauma bleeding indication for Novo's recombinant Factor VIIa hemophilia treatment will begin within six months, the company says. FDA recently lifted a clinical hold based on European safety data.
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Novo Nordisk plans to initiate a U.S. clinical trial in the next six months for NovoSeven as a hemostatic agent for bleeding related to traumatic injuries. FDA has lifted a clinical hold on studying NovoSeven (recombinant Factor VIIa) in trauma, allowing the program to proceed, Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen, PhD, said Aug. 11 on the company's second quarter earnings call. "The FDA has historically been cautious regarding the safety profile of NovoSeven," Thomsen said. "What actually has made them convinced this time around…is because they have seen the safety database in young male trauma victims…combined with the efficacy that we saw" in European trials. Novo Nordisk plans to file NovoSeven for blunt trauma in the EU in the first quarter of 2005. FDA approved NovoSeven in 1999 for treatment of bleeding episodes in hemophilia patients. The U.S. trauma trial will measure a composite endpoint, Thomsen said. "We will not be looking at mortality," and FDA "probably will not allow approval based on blood transfusion" levels alone. "Hence…there will likely be a composite endpoint," typically comprising "one or more elements of bleeding and the complications of bleeding, ranging from" acute respiratory distress syndrome, multiple organ failure, "all the way down to mortality," Thomsen said. The study will use only a single dosing regimen, Thomsen noted. Because "there is a huge variability in the plasma levels obtained in two patients receiving exactly the same dose," the regulators in the U.S. and Europe "have clearly accepted that you cannot, with any clinical meaningfulness, do dose escalation or dose differentiation in these patients," Thomsen said. The trial will compare placebo to an initial dose of 200 micrograms, followed by two additional doses of 100 micrograms if necessary. The need for further trials will be based on the outcome of the first study, Thomsen said. "We've learned, you cannot really call things either 'Phase II' or 'Phase III' in this area," Thomsen said. "If you end up with a study that is either terminated prematurely or on time with very significant findings, then it's hardly ethical to conduct further clinical studies." - Elizabeth Walker |