Novartis’ Expansion Of Menveo Further Set Back By “Complete Response”
This article was originally published in The Pink Sheet Daily
FDA issues “complete response” for an sBLA that would expand use of Novartis’ meningitis vaccine in children aged two months to 24 months, which could have offered a competitive advantage against Sanofi’s market-leading Menactra.
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The EU CHMP’s recommendation in favor of Novartis’ Meningitis B vaccine Bexsero is a positive turn for the company’s vaccines business, but with the division’s sales and profits languishing, some investors are wondering if Novartis should cut its losses and get out of the space.
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FDA has extended approval of the meningococcal disease vaccine to children as young as nine months, but if the CDC recommends it only for high-risk groups the expanded market could be limited.