Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

Nine new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.

The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents.

A positive opinion was adopted for Finlee* (dabrafenib) for the treatment of glioma, a type of brain tumour that begins in glial cells, the cells that surround and support nerve cells.

The Committee gave a positive opinion for Vanflyta* (quizartinib), for the treatment of adult patients with diagnosed acute myeloid leukaemia, a cancer of the blood and bone marrow.

Yorvipath* (palopegteriparatide), a parathyroid hormone replacement therapy, received a positive opinion for the treatment of chronic hypoparathyroidism in adults. Hypoparathyroidism is a disorder in which the glands in the neck do not produce enough parathyroid hormone…