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news.Nabi Biopharmaceuticals has submitted a marketing authorization application to European regulators for approval to market StaphVAX within the EU. The indication sought under this initial EU license application is for the prevention of staphylococcus aureus bacteremia in patients with end-stage renal disease on hemodialysis for up to 40 weeks.
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The marketing authorization application (MAA) filing will be based on data from the previously completed phase III clinical trial of StaphVAX in end-stage renal disease (ESRD) patients.
As a result of the filing, the EMEA Committee for Medicinal Products for Human Use (CHMP) will evaluate the company’s application to determine whether to approve the marketing of StaphVAX. Upon approval, Nabi Biopharmaceuticals would be allowed to market StaphVAX in all 25 member states of the EU once reimbursement approval for each country has been obtained.
“This filing represents a very significant milestone in our transformation to become a fully integrated biopharmaceuticals company,” stated Thomas McLain, chairman, CEO and president of Nabi Biopharmaceuticals. “This is our first application for a vaccine product and first application for a product developed fully from bench top to license submission by Nabi Biopharmaceuticals.”
Mr McLain continued, “This filing is also an important milestone for advancing our nephrology franchise and for building our commercial presence in Europe. Staph aureus infections represent one of the EU’s most pressing public healthcare concerns. We believe that preventing Staph aureus infections before they harm patients may become an important standard of care in the EU and around the world.”
Nabi Biopharmaceuticals plans to file a supplemental MAA in the EU upon approval of this initial application that incorporates data from its second phase III clinical trial in the US and data from a number of immunogenicity studies in other at-risk patient populations conducted in the EU and the US. The supplemental MAA filing will seek a broader indication for StaphVAX in preventing staph aureus bacteremia in other at-risk adult patient populations.