Biovest Formally Notifies European Agency for BiovaxID

Biovest International has formally made notification to the European Medicines Agency (EMA) regarding their intent to file a Marketing Authorization Application (MAA) for approval in the European Union (EU) for the company's leading oncology product, BiovaxID, a personalized cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma.

If approved by the EMA, BiovaxID would become the first cancer vaccine available in Europe for lymphoma patients.

The process involves having the application assessed by the EMA's Committee for Medicinal Products for Human Use (CHMP). Following a positive assessment, Biovest could reach the European market in under 12 months.

"This formal notice submitted to the EMA marks a significant milestone in our BiovaxID global regulatory strategy," said Carlos F. Santos, Ph.D., Biovest's Senior Vice President, Product Development and Regulatory Affairs, "This is the initial step required by the EMA in the process leading up to our planned MAA submission."

Biovest has chosen to seek marketing approval for BiovaxID in Europe after receiving guidance at pre-filing clinical advisory meetings with EU-member national regulatory agencies.

Biovest has intentions to seek marketing approval in the US with the Food and Drug Administration soon.

Source: MarketWatch