Reuters: Regulatory News: UPDATE 1-Novartis wins EU okay for first meningitis B vaccine

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

UPDATE 1-Novartis wins EU okay for first meningitis B vaccine Nov 16th 2012, 12:33 By Ben Hirschler LONDON | Fri Nov 16, 2012 7:33am EST 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 causes 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. Securing European backing for Bexsero 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 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. 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

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions