Novartis has received a couple of pieces of good news from regulators in the USA this morning who have approved its meningococcal vaccine Menveo and granted a priority review for the Swiss major’s investigational oral treatment for multiple sclerosis fingolimod.

First up, the US. Food and Drug Administration has given the green light to Menveo which is now licensed to help protect against potentially deadly meningitis and sepsis caused by four common vaccine-preventable serogroups. The approval, which covers the ages of 11 to 55, is primarily based on data from a Phase III head-to-head trial that compared Menveo to the other approved vaccine for the A, C, W-135 and Y serogroups, Sanofi-Pasteur’s Menactra.

Novartis’ head of vaccines and diagnostics, Andrin Oswald, noted that some 16 million adolescents between 11-18 “are at risk and remain unprotected against meningococcal disease”. The company, which is hoping to get European approval soon, now expects to file data to support an infant indication in the USA in 2011.

Meantime the FDA has granted priority review status to Gilenia (fingolimod), previously also known as FTY720, which cuts the standard review time on the MS drug to six months from ten.

The news means that Novartis appears to have moved ahead of Merck KGaA in the battle to get an oral treatment for MS onto the market. At the end of last year, the German received a ‘refuse to file’ letter from the FDA for cladribine.

However Novartis also noted that since Gilenia involves a new active ingredient, the FDA is likely to require an advisory committee meeting and evaluate the firm’s risk management programme. This could result in the agency extending its review at the end of the six-month period.