Biovest International, Inc., whose manufacturing plant is in Coon Rapids, recently had a regulatory meeting with the European Medicines Agency (EMA) in London, England.
The EMA provided Biovest with information to help finalize Biovest’s pending Marketing Authorization Application (MAA) seeking EU marketing approval for BiovaxID.
The meeting addressed legal, regulatory and scientific matters for the planned MAA to facilitate subsequent application validation and assessment.
Biovest believes that the meeting with the EMA was favorable and will support final preparation and filing of the MAA anticipated for early next year, according to the press release.
Based on the meeting, Biovest anticipates that the filing and review of the application will proceed in a timely and customary manner. Next steps in the pre-submission process will include upcoming meetings planned with the rapporteur and co-rapporteur.
They are members of the EMA’s Committee for Medicinal Products for Human Use (CHMP) and are supported by a team of assessors from their national authority.
The rapporteur and co-rapporteur have been assigned with the primary responsibility of preparing and delivering an approvability evaluation report under the EMA’s centralized procedure.
Under this procedure, a registration of BiovaxID throughout all EU-member countries can be obtained simultaneously via a single application.
On approval, BiovaxID would be the first cancer vaccine available in Europe for lymphoma patients, the press release states.
Headquartered in Tampa, Fla., Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.