Sanofi-Aventis' Menactra Demonstrates Noninferiority To Menomune, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The meningococcal vaccine Menactra met its primary safety endpoint of noninferiority in severe systemic adverse events. Sanofi-Aventis failed to show lot consistency within predefined equivalence limits, FDA says.
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Sanofi-Aventis' quadrivalent meningococcal vaccine Menactra demonstrated noninferiority to Menomune based on immune response, FDA's Office of Biostatistics & Epidemiology says. "The results of the clinical trials demonstrated non-inferiority (with respect to immunogenicity) of" Menactra "compared to Menomune by the SBA-BR method for the 11-55 age group," OBE's 1 statistical review and analysis says. FDA will bring the Menactra application before the Vaccines & Related Biological Products Advisory Committee Sept. 22 for review (2 (Also see "Aventis/VaxGen AIDS Vaccine Phase III Update Will Be Heard By Advisory Committee Sept. 23" - Pink Sheet, 18 Aug, 2004.)). [Editor's Note: To 3 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] Sanofi-Aventis is seeking an indication for "active immunization of adolescents and adults 11 to 55 years of age for prevention of invasive meningococcal disease cause by N. meningitides serogroups A, C, Y, and W-135." Menomune is contraindicated in patients sensitive to thimerosal. Sanofi-Aventis notes that Menactra "contains no preservatives" in its 4 briefing document. In addition to immunogenicity, Menactra will need to show safety noninferiority, as well as lot consistency, FDA's 5 briefing documents says. Menactra met its primary safety endpoint of noninferiority in "proportion of patients with at least one severe solicited systemic reaction," Sanofi-Aventis says. However, the company acknowledged that "local reactions were more frequently reported in Menactra recipients than in Menomune recipients." Sanofi-Aventis said this "was not unexpected given the nature of the vaccine." "The results of the lot consistency evaluation indicate that serogroups C and Y did not meet the primary objective of the predefined equivalence limit of 1.5 for the GMT ratios," FDA's review states. Sanofi-Aventis expects Menactra will be approved this year; the application was submitted Dec. 18, 2003 (6 (Also see "Aventis Menactra May Get CDC Endorsement For Teens And College Freshmen" - Pink Sheet, 6 Jul, 2004.)). The Centers for Disease Control & Prevention favors a recommendation of routine meningococcal vaccination for adolescents and college freshmen in dorms. - Andrew Kasper |