(Reuters) – Novartis said U.S. health regulators have granted the Swiss drugmaker’s meningitis B vaccine Bexsero breakthrough therapy status.
The Basel-based company in a statement on Monday said it plans to file for U.S. approval of Bexsero as early as the second quarter of this year.
Bexsero is widely seen as crucial to Novartis’ vaccines business, which has struggled to catch market leaders GlaxoSmithKline, Sanofi and Merck. The business was the only one of Novartis’ five divisions to report a full-year operating loss in 2013.
The vaccine already has approval in Europe, Canada and Australia and has been administered at several universities in the United States to stop outbreaks of meningitis across campuses.
(Reporting by Caroline Copley; Editing by Christopher Cushing)