Biovest Seeks European Approval for BiovaxID

Biovest is announcing that it intends to file for marketing approval in the European Union (EU) for BiovaxID, the company's personalized theraoeutic cancer vaccine for treating follicular non-Hodgkin's lymphoma.

The company will file a Marketing Authorization Application (MAA), with the European Medicines Agency (EMA), the regulatory agency responsible for the scientific evaluation of applications for the EU. Should it be approved, EMA approval would make BiovaxID the first cancer vaccine available in Europe for lymphoma patients.

Biovest chose to seek EU marketing approval based on pre-filing clinical advisory meetings with EU-member national regulatory agencies.

Under procedures established by the EMA, Biovest will simultaneously seek marketing approval for BiovestID for all members of the European Union.

"Biovest’s EU regulatory strategy focused on conducting pre-filing clinical meetings with national regulatory agencies to obtain scientific advice regarding our BiovaxID clinical data and to facilitate a more predictable marketing approval process in the European Union," said Samuel S. Duffey, Esq., Biovest’s President & CEO, stated, "Today’s announcement confirms that pre-filing meetings have been conducted in Europe, and the Company intends to file a marketing application with the EMA. This is a major regulatory milestone, and it builds on Biovest’s recently announced plans to seek marketing approval in Canada following a pre-filing meeting with Health Canada. We next look forward to meetings with the FDA to define the path to U.S. registration as well.”

The next step in the company's regulatory strategy is to meet with the U.S. Food & Drug Administration.

Source: Biovest