Soligenix announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for „the prevention and post-exposure prophylaxis against MARV infection.“
MarVax™ is a subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawai?i at M?noa. The vaccine includes a protein found on the surface of MARV, to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with Generally Regarded as Safe (GRAS) excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use.
