Reuters: Regulatory News: UPDATE 2-Novartis wins EU okay for first meningitis B vaccine

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UPDATE 2-Novartis wins EU okay for first meningitis B vaccine Nov 16th 2012, 13:22 Fri Nov 16, 2012 8:22am EST * European Medicines Agency recommends Bexsero * Decision likely to be formally endorsed in 2-3 months * Uptake of vaccine hinges on support from governments By Ben Hirschler LONDON, Nov 16 (Reuters) - The first vaccine against meningitis B has been recommended for approval in Europe in a boost for its maker Novartis, which has struggled in the vaccines field against larger rivals. The European Medicines Agency (EMA) said on Friday that its experts had given a green light to Bexsero for the prevention of "MenB". There is currently no approved vaccine offering broad protection against this particular type of meningitis. MenB is caused by bacteria, leading to inflammation of the lining around the brain and spinal cord. It can kill within 24 hours and infants are at highest risk. Around 10 percent of those who contract the disease die, despite appropriate treatment, and up to 20 percent of survivors suffer from serious disabilities such as brain damage and hearing impairment. Securing European backing for Bexsero for use from two months of age is a vindication of the Swiss drugmaker's research in vaccines, where it lags behind market leaders GlaxoSmithKline , Sanofi and Merck. The company is pinning high hopes on Bexsero - which is the result of more than 20 years of vaccine research - and the new product will complement another meningitis vaccine it already has on the market called Menveo that covers other strains of the disease. Recommendations from the EMA are normally endorsed by the European Commission within a couple of months. That will allow Novartis to launch Bexsero in 2013 - but its commercial success still depends on whether individual governments then decide to add it to routine vaccination programmes. Novartis said it was committed to making Bexsero available "as soon as possible" and was already engaging with governments interested in its early adoption. Tim Anderson, an industry analyst at Bernstein, believes getting Bexsero widely adopted may not be easy because although MenB is a serious disease with high mortality, its incidence is declining. "If the disease occurs only rarely, then it may not make sense to administer the vaccine broadly as a preventive measure," Anderson said in a research note before the EMA decision. In the United States, Novartis is still working with authorities to design U.S.-specific Phase III clinical trials. Link this Share this Digg this Email Reprints

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