Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting.

The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) for the treatment of neovascular (‘wet’) age-related macular degeneration, a disease that affects the central part of the retina at the back of the eye and causes loss of ‘straight-ahead’ vision.

The CHMP adopted a positive opinion for Recarbrio (imipenem / cilastatin / relebactam), for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

The biosimilar medicine Amsparity (adalimumab) received a positive opinion for the treatment of certain inflammatory and autoimmune disorders.

The CHMP recommended granting marketing authorisations for two generic medicinesAzacitidine Accord (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia, diseases in which the body produces large numbers of abnormal blood cells; and Dexmedetomidine Accord (dexmedetomidine), for the induction of light to moderate sedation of adults in an intensive care unit.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for AkynzeoCyramzaDarzalexDificlirErleadaSirturo, Stelara and Vyndaqel.

Posted on the EMA website on 13 December 2019