Sanofi-Aventis' Menactra Post-Approval Commitments Should Include Long-Term Safety, Efficacy Data
This article was originally published in The Pink Sheet Daily
Executive Summary
The quadravalent meningococcal conjugate vaccine displayed immunogenicity and safety similar to Menomune, an FDA Advisory Committee says. Sanofi-Aventis says that preliminary results from a three-year follow-up study suggest that Menactra patients have longer antibody persistence than Menomune.
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Sanofi-Aventis should commit to long-term efficacy and safety post-approval studies for its meningococcal conjugate vaccine Menactra , an FDA advisory committee said. "I think there is going to be needed data regarding persistence of antibody and…also when boosters would be required," Vaccine & Related Biological Products Advisory Committee Chair Gary Overturf, MD (University of New Mexico), said at the committee's Sept. 22 meeting. Sanofi-Aventis cited the potential for longer antibody persistence, the ability to prime and boost, absence of hyporesponsiveness and strengthening of herd immunity as possible advantages of the conjugate vaccine over its polysaccharide meningococcal vaccine Menomune . The company presented some long-term efficacy results from one follow-up study to the committee. However, the data has not been submitted to, or reviewed, by FDA. In 241-patient, three-year follow-up study MTA19, Menactra patients displayed significantly longer anti-body persistence in serogroups A, C, Y and W-135 than those receiving Menomune, Sanofi-Aventis said. Menactra patients receiving boosters after three years also possessed more antibodies than vaccine naïve patients receiving Menactra for the first time, the company added. Sanofi-Aventis said that it plans to conduct five- and seven-year follow-up studies as well. The committee voted unanimously that Menactra was shown to be non-inferior to Menomune with regard to immunogenicity and safety . [Editor's Note: To watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] Menactra antibody response rates in adolescents ranged from 82% to 97% compared to 80%-95% for Menomune depending on the patients' serogroup. Adult response rates ranged from 74% to 89% for Menactra compared to 80%-94% for Menomune. "The data strongly supports" the demonstration of non-inferiority to Menomune, Overturf said. FDA agreed that Menactra demonstrated immunogenicity and safety non-inferiority to Menomune (1 (Also see "Sanofi-Aventis' Menactra Demonstrates Noninferiority To Menomune, FDA Says" - Pink Sheet, 21 Sep, 2004.)). Committee members said that they would like to see further data about receiving Menactra concomitantly with other vaccines. Sanofi-Aventis presented data on the concomitant use of Menactra with the Td vaccine and the Typhim Vi typhoid vaccine; concomitant use did not affect any vaccine safety or efficacy, Sanofi-Aventis said. - Andrew Kasper |