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Novartis must boost Menveo trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis must add 1,500 pediatric patients to its safety database for Menveo before FDA will approve the meningococcal meningitis vaccine for use before age 11. The firm filed a BLA for Menveo (MenACWY-CRM) in August 2008 for ages 11-55, targeting four strains of meningococcal meningitis: A, C, W-135 and Y. An ongoing Phase III program is evaluating the vaccine in infants and children two months to 10 years old, and it is this program that the agency said was not powered for its endpoints. During a Jan. 28 earnings call, Novartis Vaccines and Diagnostics CEO Andrin Oswald said "this reflects a safety standard that FDA has now made us aware of, and it had not been discussed in previous discussions before we started the Phase III." The firm has been in discussion with FDA on the Menveo outcome for "quite a while, he added. "It was unfortunate that the request came up so late." Gathering the additional data will push a U.S. filing for the pediatric population to 2011, although a European filing is still planned for 2010, the firm said. Menveo is key to Novartis' blockbuster vaccine strategy 1(Pharmaceutical Approvals Monthly May 2008, p. 18)

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