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Novartis receives complete response letter for Menveo vaccine; no new clinical trials required
Wednesday, July 01 2009 | Comments
What's This?
The Food and Drug Administration sent Novartis AG a complete response letter pertaining to the company's investigational meningococcal disease vaccine, Menveo (MenACWY-CRM), indicating that more information is needed primarily on the manufacturing portion of the Biologics License Application (BLA).Novartis said no new clinical trials were requested, and the firm expects to fully address before year-end the FDA's issues with the BLA, which was submitted last August. Novartis had expected to receive approval of the vaccine this year, but now said it could be late 2009 or early 2010 before it obtains FDA clearance, according to The Wall Street Journal.
The BLA targets a patient population aged 11 to 55 years, and the FDA earlier this year told Novartis that it needs to expand a clinical trial among children aged 2 months to 10 years to 1,500 subjects, thus delaying the company's anticipated filing of Menveo for use in younger children to 2011.
Novartis said clinical trials have shown that Menveo elicits a protective immune response against four of the most common serogroups of meningococcus, which it said account for most cases of meningococcal disease worldwide.
As previously reported, Phase III study data presented at the Pediatric Academic Societies' 2008 Annual Meeting showed that adolescents aged 11 to 18 years who received Menveo experienced a greater immune response against the four serogroups of meningococcus as compared with the adolescents who received Sanofi Pasteur Inc.'s Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate). That study included more than 2,100 participants.
Also, in January 2008, data published in the Journal of the American Medical Association from an open-label, Phase II trial showed that Menveo appeared to be well-tolerated and immunogenic in infants aged as young as 2 months.
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