Nabi Biopharmaceuticals' StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) Marketing Authorization Application (MAA) has been accepted for review by the European Medicines Evaluation Agency (EMEA). The company submitted its MAA filing with the EMEA using the centralized procedure to request marketing approval for StaphVAX for the prevention of S. aureus bacteremia in patients with end-stage renal disease (ESRD) on haemodialysis for up to 40 weeks.
According to the release, acceptance of the StaphVAX MAA for review indicates the company's submission has been administratively validated by the EMEA and the regulators believe the required information is complete and ready for review. The EMEA's Committee for Medicinal Products for Human Use (CHMP) will evaluate the company's application to determine whether to recommend approval for the marketing of StaphVAX in all 25-member states of the European Union (EU). In addition, the CHMP has officially approved the trade name StaphVAX for this product.
Thomas H. McLain, chairman, chief executive officer and president said, "Staph aureus infections represent one of the EU's most pressing public healthcare concerns, and we believe that StaphVAX could offer a new and innovative approach to prevent the deadly consequences of infections caused by this organism. We look forward to working closely with the European regulatory authorities toward the licensure of StaphVAX."
This MAA filing is based on data from the previously completed US Phase III clinical trial of StaphVAX in ESRD patients. Nabi Biopharmaceuticals also plans to file a supplemental StaphVAX MAA in the EU for the prevention of S. aureus bacteremia in at-risk adults. The filing will include data from the company's second US Phase III clinical trial along with data from its US and EU immunogenicity studies conducted in other at- risk patient populations.