Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020

Seven new medicines recommended for approval

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

The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain.

The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza.

The CHMP recommended granting a marketing authorisation under exceptional circumstances for Obiltoxaximab SFL* (obiltoxaximab), for the treatment or post-exposure prophylaxis of inhalational anthrax.

The biosimilar medicine Nyvepria (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy…