FDA says no to Novartis' Menveo vax for babies

Novartis ($NVS) has suffered a setback in its effort to expand the use of Menveo, its quadrivalent meningococcal conjugate vaccine. The FDA has turned down its application to extend the approval to infants and toddlers ages 2 months to 2 years.

Novartis submitted a supplemental biologics license application (sBLA) in April, and the FDA has come back with a complete response letter asking for answers to additional questions. While it's not yet clear what additional information is needed, Novartis has stated that it will be working with the FDA.

Menveo protects against group A, C, Y and W-135 meningococcal infections. The FDA approved it for use in 11- to 55-year-olds in February 2010, and for 2- to 10-year-olds in January 2011. Studies are ongoing in infants, toddlers, adolescents and adults. However, the vaccine has not had a smooth path to the market--the FDA returned its initial submission in July 2009, asking for more information.

The market for meningococcal vaccines in infants is a large one--Dow Jones reported predicted peak annual sales for Menveo of $800 million--and any holdups in approval could have quite an impact.

"This additional delay further postpones approval in this all-important age group, and puts it at a further disadvantage to [rival] Sanofi's ($SNY) Menactra," Karl-Heinz Koch, an analyst at Helvea, told Dow Jones.

- read the press release
- check out the article in Dow Jones