CHMP recommends five new drugs, gives advice on Celltrion COVID antibody

Regulatory NewsRegulatory News | 26 March 2021 |  By 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday issued positive opinions for five new medicines and six extensions of therapeutic indications following its meeting earlier this week.
The newly recommended medicines include Verastem’s Copiktra (duvelisib) to treat relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma and Janssen-Cilag’s multiple sclerosis treatment Ponvory (ponesimod). The committee also recommended two oral contraceptives with the same active substances, Gedeon Richter’s Drovelis (estetrol/drospirenone), Estetra SPRL’s Lydisilka (estetrol/drospirenone), and Diurnal Europe BV’s hybrid medicine Efmody (hydrocortisone) for patients 12 and older with congenital adrenal hyperplasia (CAH).
The six medicines that received extensions of indication are GlaxoSmithKline’s Benlysta (belimumab), Vertex Pharmaceuticals’ Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor), Novo Nordisk’s Saxenda (liraglutide), Roche’s Tecentriq (atezolizumab) and Astellas’ Xtandi (enzalutamide).
The committee also provided harmonized scientific advice for national health authorities on the use of Celltrion’s monoclonal antibody regdanvimab to treat COVID-19. Despite unclear evidence about the medicine’s benefits, the committee said the medicine could be used to treat COVID-19 in adults who do not require supplemental oxygen therapy and who are at high risk for severe COVID-19.
The recommendation was based on interim study data that showed regdanvimab may reduce the rate of hospitalization among patients receiving the treatment. “However, the results were not robust enough to reach a firm conclusion on the medicine’s benefits at this point in time,” EMA writes.
CHMP’s advice follows a review of regdanvimab under Article 5(3) of Regulation (EC) No 726/2004. The drug is also undergoing a rolling review in pursuit of an EU-wide marketing authorization.
EMA, Statement on regdanvimab


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