Bavarian Nordic announced on May 31 that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization for IMVANEX, an immunization against smallpox.
IMVANEX, also known as IMVAMUNE, is a vaccination for both healthy adults and those with autoimmune deficiencies, such as HIV positive people. It was filed for marketing using clinical data from 3,400 people. CHMP found IMVANEX to have a favorable benefit-risk balance and recommended it for regular immunization and marketing.
The European Commission will make the final authorization on marketing. The final decision is expected to take three months and will be applicable to all European Union member states and European Economic Area countries, including Iceland, Liechtenstein and Norway.
"We are pleased to receive a positive opinion from the European authorities and we look forward to the decision by the European Commission," President and CEO of Bavarian Nordic Anders Hedegaard said. "This represents a significant milestone and scientific breakthrough for our company and our MVA-BN vaccine technology platform, which we have taken from early research through clinical development and the anticipated regulatory approval in just a decade."
When and if the final marketing authorization is approved, the drug will be available for commercial use in the EU and EEA. Hedegaard said Bavarian Nordic will work diligently with each governing body to meet national preparedness plans to ensure at-risk populations are protected against smallpox.