COPENHAGEN (Reuters) - Danish biopharma firm Bavarian Nordic has submitted a marketing authorization application to the European Medicines Agency (EMA) for its smallpox vaccine to be marketed under the name of Imvanexr in Europe, the company said on Thursday.
A successful review could lead to a market authorization for Imvanexr in Europe in 2013, Bavarian Nordic said in a statement.
The filing to the EMA follows a New Drug Submission to Health Canada in 2011, which is under review and is expected to result in market approval for the vaccine in Canada this year, Bavarian Nordic said.
“If found acceptable by EMA, Imvanexr will be indicated for active immunization against smallpox infection and disease in persons 18 years of age and older,” Bavarian Nordic said.
The vaccine, under the name Imvamuner, has so far to the U.S. government for stockpiling.
If the applications in Europe and Canada are approved, it would “greatly expand the market opportunities worldwide beyond the current sales to the U.S. government,” Chief Executive Anders Hedegaard said in the statement.
Reporting by John Acher; Editing by David Holmes