EMA Expert Panel Recommends Five Drugs, Endorses Celltrion’s Regdanvimab for COVID-19
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval at its monthly meeting last week — and issued a positive review of Celltrion’s monoclonal antibody, regdanvimab, for treatment of COVID-19.
The committee specifically recommended the antibody’s use to treat COVID-19 patients who don’t require supplemental oxygen and who are at high risk of progressing to severe disease.
The advisory group also recommended a marketing authorization by the European Commission for Janssen’s Ponvory (ponesimod) for active relapsing types of multiple sclerosis, and for Verastem Europe’s Copiktra (duvelisib), for adults with relapsed or refractory chronic lymphocytic leukaemia or refractory follicular lymphoma.
In addition, the committee issued positive opinions for two oral contraceptives, Gideon Richter’s Drovelis and Mithra Pharmaceuticals’ Lydisilka, both containing the active substances estetrol and drospirenone. It also endorsed Diurnal Group’s Efmody (hydrocortisone) for treatment of congenital adrenal hyperplasia in patients 12 years and older.
The CHMP also recommended the following therapeutic extensions:
- GlaxoSmithKline’s lupus drug Benlysta (belimumab) for adults with autoantibody-positive systemic lupus erythematosus;
- Vertex Pharmaceuticals’ combination therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor) for treating cystic fibrosis patients 12 years and older with a specific mutation, which includes expanding Vertex’s indication for Kalydeco (ivacaftor);
- Novo Nordisk’s Saxenda (liraglutide) for treating obesity in adolescents;
- Roche’s cancer drug Tecentriq (atezolizumab) as a monotherapy for the first-line treatment of adults with metastatic nonsmall-cell lung cancer whose tumors significantly express programmed-death ligand 1; and
- Astellas Pharma’s Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer when combined with androgen deprivation therapy.
― Jason Scott