From their meeting in March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
March’s virtual meeting saw eight medicines recommended for approval including four new medicines, three orphan medicines and one biosimilar.
The Committee recommended granting a conditional marketing authorisation for an advanced therapy medicinal product (ATMP) called Zolgensma (onasemnogene aberparvovec), for spinal muscular atrophy in babies and young children. This genetic disease is rare and often fatal. Fluad Tetra, (influenze vaccine) was granted a marketing authorisation as well as Sarclisa (isatuximab) for the treatment of multiple myeloma.
Asthma inhalers Atectura Breezhaler and Bemrist Breezhaler, which both contain the active ingredients indacaterol and mometasone furoate, received positive opinions from the CHMP. Pretomanid FGK (pretomanid) for tuberculosis and Zeposia (ozanimod) for active relapsing remitting multiple sclerosis also received positive opinions. The biosimilar Nepexto (etanercept) was recommended for the treatment of various types of arthritis, spondyloarthritis and psoriasis.
Furthermore, there were six recommendations for extensions of therapeutic indication, including Adcetris, Cocentryx, Intelence, Jorveza, Kineret and Ruconest. The application for an initial marketing authorisation for Doxorubicin Hydrochloride Tillomed was withdrawn, as well two medicines containing rituximab.
The CHMP also reported outcomes of various reviews of conditions of use for oral anticoagulants, fosomycin and methocarbamol/paracetamol containing medicines.
A detailed report of the meeting outcomes can be found here.
Additionally, the CHMP have given recommendations on the compassionate use of the investigational antiviral medicine remdesivir in treating COVID-19. Find out more about compassionate use programmes here.