* Novartis to resubmit Menveo infant indication in few mths
* Novartis believes concerns raised are of procedural nature
* U.S. approves Menveo in children from two years of age
* Novartis shares 0.2 pct higher, slightly better than index
(Adds shares, analyst comment)
ZURICH, Jan 31 (Reuters) - Novartis’s NOVN.VX vaccine against meningococcal disease, a cause of potentially deadly meningitis, failed to get U.S. backing for use in infants, in a small setback to the Swiss group’s Vaccine and Diagnostic unit.
The Menveo vaccine, which is already approved in the United States for adolescents and adults from the age of 11 to 55 years, did, however, get backing for use in children from two years of age.
Novartis is hoping its meningitis franchise will help its Vaccines and Diagnostics unit to reduce its dependency on sales from pandemic vaccines. [ID:nLDE70Q11K]
“The approval expands the use of Menveo, but importantly the FDA issued a Refuse to File letter regarding the use of Menveo in infants from 2-12 months,” Kepler Capital Markets analyst Tero Weckroth said, adding this was a minor negative.
At 0902 GMT, Novartis shares were trading 0.1 percent higher, outperforming a slightly weaker European healthcare index .SXDP.
Vontobel’s Andrew Weiss said the approval of Menveo in children from two to 10 years of age was expected and that he was sticking to his peak sales estimate of $800 million.
Novartis said it believed the concerns raised by the FDA for the vaccine in infants between two months and 12 months were “of procedural nature” and said it planned to resubmit its label extension application within a few months.
“This will also provide us with an opportunity to supplement the file with additional clinical data that support expanded use of Menveo in infants and toddlers from two months to two years old,” Andrin Oswald, head of Novartis’s Vaccines and Diagnostics unit, said in the statement. (Reporting by Katie Reid; Editing by David Holmes and Will Waterman)