Cangene has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) regarding the immunoprophylaxis indication of its ImmunoGam (Human Hepatitis B Immunoglobulin).
The company said that the product is marketed as HepaGam B in North America and Israel, and is a hyperimmune antibody product containing antibodies specific for the hepatitis B surface antigen. A marketing authorisation from the European Commission should follow within 67 days following adoption of the opinion.
Reportedly, the Marketing Authorisation Application (MAA) for Cangene’s Human Hepatitis B Immunoglobulin was submitted to the EMA via the centralised procedure. Under this, an approval is expected to apply to all 27 member states of the EU. Details regarding distribution and launch plans are still being determined.
John Langstaff, president and CEO of Cangene, said: “This is another positive regulatory step for this product. This approval is for a relatively small and competitive market; nevertheless, it continues to expand our international footprint and our regulatory experience with various jurisdictions.”
Cangene manufactures its Hepatitis B Immune Globulin in its Winnipeg facility using a process similar to that of WinRho SDF, Vaccinia Immune Globulin (VIG) and VariZIG, the company’s other hyperimmune products that have been approved in the US and Canada.