Approval of six novel meds recommended at EMA/CHMP May meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six novel medicines for approval at its May 2020 meeting. The recommendations will now to the European Commission, which usually provides its final decision within two or three months.

The Committee recommended granting a marketing authorization for a new vaccine that provides active immunisation to prevent Ebola virus disease in individuals aged one year and older. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), both from Janssen-Cilag International, a unit of Johnson & Johnson (NYSE: JNJ). Zabdeno is given first and Mvabea is administered eight weeks later as a booster. Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need. If the Ebola vaccine regimen is approved by the European Commission, this will be Janssen's first vaccine approval.

The CHMP recommended granting a marketing authorization for Hepcludex (bulevirtide), from German biotech MYR GmbH, for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D, Hepcludex benefited from the support of the PRIME scheme, the EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.