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.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Benlysta, Kaftrio, Kalydeco, Saxenda, Tecentriq and Xtandi.
Withdrawal of application
An application to extend the use of Brilique (ticagrelor) with aspirin (acetylsalicylic acid) to prevent problems caused by blood clots in adults with coronary artery disease and type 2 diabetes was withdrawn.
COVID-19: Outcome of review on the use of regdanvimab
The CHMP gave a recommendation to define conditions of use for the monoclonal antibody regdanvimab (also known as CT-P59). This medicine is currently not authorised in the EU, but the recommendation provides a harmonised scientific opinion at EU level to support national decision making on the possible use of this antibody to treat confirmed COVID-19 in patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.