Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.

The Committee recommended granting a marketing authorisation 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). Zabdeno is given first and Mvabea is administered approximately 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. For more information, see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Hepcludex* (bulevirtide), 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, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.

Piqray (alpelisib) received a positive opinion from the CHMP for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.

The CHMP recommended granting a conditional marketing authorisation for Rozlytrek (entrectinib), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer…