The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended five new medicines for approval at its March meeting, as well as six recommendations of current indications.
Firstly, the committee recommended Verastem Oncology’s Copiktra (duvelisib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL).
The committee also adopted a positive opinion for Janssen’s Ponvory (ponesimod) for the treatment of active relapsing form of multiple sclerosis.
In response to the CHMP recommendation, Janssen Research & Development’s global therapeutic head for neuroscience Bill Martin said: “the positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research which ultimately showed the treatment offers RMS patients superior efficacy on the primary endpoint of reduced annualised relapse rate compared to an established therapy, as well as a proven safety profile.”
Next, the committee recommended granting a marketing authorisation for Gedeon Richter’s Drovelis, as well as its duplicate Lydisilka, manufactured by Estetra.
Both medicines contain the active substances estetrol and drospirenone, receiving positive opinions for use as oral contraceptives.
The last new medicine to receive a positive opinion was hybrid medicine Efmody (hydrocortisone modified-release hard capsules), from Diurnal, for the treatment of congenital adrenal hyperplasia (CAH) in patients aged 12 years and over.
The committee also recommended the extensions of indication for GlaxoSmithKline’s Benlysta (belimumab) as an add-on therapy in patients with active lupus nephritis, as well as Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) for cystic fibrosis (CF) patients with at least one F508del mutation in the CFTR gene.
Vertex also scored a positive opinion for a label extension of its other CF treatment Kalydeco (ivacaftor), while Novo Nordisk’s Saxenda (liraglutide 3.0 mg) has been recommended for a new indication for the treatment of obesity in adolescents aged 12-17 years.
Rounding out the new label extension recommendations was Roche’s Tecentriq (atezolizumab) as a first-line treatment for metastatic non-small cell lung cancer patients, and Astellas Pharma’s Xtandi (enzalutamide) for the treatment of patients with metastatic hormone-sensitive cancer.
The CHMP also announced the withdrawal of an application to extend the use of AstraZeneca’s Brilique (ticagrelor) with aspirin to prevent problems caused by blood clots in adults with coronary artery disease and type 2 diabetes.
Finally, the CHMP gave a recommendation to define conditions of use for Celltrion’s monoclonal antibody regdanvimab (also called CT-P59).
The recommendation provides a harmonised scientific opinion at the EU level to support national decision making on the possible use of this drug to treat confirmed COVID-19 in patients who do not require supplemental oxygen therapy and who are at-risk of progressing to severe COVID-19. The antibody is currently not authorised in the EU.