BiovaxID Takes Another Step Towards European Market Approval

Biovest, makers of the coming personalized lymphoma therapeutic vaccine BiovaxID, are announcing today that the European Medicines Agency (EMA) has notified Biovest of the official designation of the Rapporteur and Co-Rapporteur for BiovaxID.

"This is another key milestone as part of the formal EMA process and a precursor to the upcoming filing of our Marketing Authorization Application (MAA) for BiovaxID," said Biovest’s EU regulatory advisor, Adriaan Fruijtier, in a statement. "We look forward to meeting with our selected reviewers, as we will work closely with them, providing the necessary support for a comprehensive submission."

The EMA System

The way it works is that the regulatory agency of one of the EU Member States is appointed as Rapporteur; that agency will then carry out the initial assessment of the company's application for Marketing Authorization as well as determine drug safety. It is supported in that work by a second agency, designated as Co-Rapporteur.

Together, these two EU regulatory agencies will prepare and deliver an "approvability evaluation report" under the centralized procedure of the EMA. This will allow Biovest to apply for market approval to every EU member country in a single application.

Both Rapporteur and Co-Rapporteur are members of the EMA’s Committee for Medicinal Products for Human Use (CHMP).

"For [follicular lymphoma] patients that achieve a complete remission following induction therapy, BiovaxID represents the only non-immunosuppressive, highly-safe consolidation (maintenance) therapy capable of significantly extending a patient’s remission," said Carlos F. Santos, Ph.D., Biovest’s Senior Vice President, Product Development and Regulatory Affairs.

"For these patients in first remission, our primary goal is [to] deliver a treatment option that offers a likelihood of clinical benefit with quality of life not being adversely affected.”

Source: Biovest