Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2021 meeting.

The Committee recommended granting a marketing authorisation for Copiktra (duvelisib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL).

The CHMP adopted a positive opinion for Ponvory (ponesimod) for the treatment of active relapsing forms of multiple sclerosis.

Drovelis and its duplicate Lydisilka, both containing the active substances estetrol and drospirenone, received positive opinions from the Committee for use as oral contraceptives.

The CHMP recommended granting a marketing authorisation for the hybrid medicine Efmody* (hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in patients aged 12 years and over. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data…