Green light for 8 new medicines

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended eight medicines for approval at its June 2020 meeting.

This brings to 49 the total number of new drugs approved in the first half of 2020.

The Agency’s key decision-making body granted a conditional marketing authorisation for Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen.

Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. It has been shown to improve outcomes in patients with severe disease. However, following its approval, the drug has been in high demand, with reports that the US has pre-purchased global supplies for at least the next three months.

The CHMP recommended granting a conditional marketing authorisation for Idefirix (imlifidase), the first treatment for adult patients waiting for a kidney transplant who are highly sensitised against tissue from the donor and who have a positive crossmatch test against an available kidney from a deceased donor. Idefirix benefited from the support of the PRIME scheme, the EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.  

The Committee recommended granting a marketing authorisation for Kaftrio (elexacaftor / tezacaftor / ivacaftor), the first triple combination therapy for the treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. This treatment is expected to provide a new therapeutic option for many cystic fibrosis patients, including those with MF mutations where no treatment exists.  

The CHMP recommended granting marketing authorisations for three biosimilar medicines: Aybintio (bevacizumab), for the treatment of various cancers; and Livogiva (teriparatide) and its duplicate Qutavina (teriparatide), for the treatment of osteoporosis.

The Committee also backed two hybrid medicines: Gencebok (caffeine citrate), for the treatment of primary apnoea (interruption of breathing) of premature newborns; and Methylthioninium chloride Cosmo (methylthioninium chloride), intended as a diagnostic agent to enhance visualisation of colorectal lesions. 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.

The watchdog published extensions of therapeutic indication for Cosentyx, Epclusa, Remsima, Xolair and Zavicefta.