From their meeting in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
June’s meeting saw eight medicines recommended for approval including one new medicine, two orphan medicines, three biosimilars, and two hybrid medicines.
The most significant recommendation was for Veklury (remdesivir), which is the first treatment recommended for authorisation in the EU for COVID-19 patients with pneumonia who require supplemental oxygen.
A conditional marketing authorisation was also recommended 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 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.
The CHMP also recommended marketing authorisations for three biosimilar medicines. Aybintio (bevacizumab) for the treatment of various cancers, Livogiva (teriparatide) and Qutavina (teriparatide) for the treatment of osteoporosis all received favourable decisions.
Gencebok (caffeine citrate), for the treatment of primary apnoea of premature newborns, and Methylthioninium chloride Cosmo (methylthioninium chloride) intended as a diagnostic agent to enhance visualisation of colorectal lesions, were recommended for marketing authorisations through hybrid applications.
Furthermore, there were five recommendations for extensions of therapeutic indications, including Cosentyx, Epclusa, Remsima, Xolair and Zavicefta. However, there was one negative opinion adopted by the CHMP, for Turalio (pexidartinib). Applications for initial marketing authorisations for Sondelbay (teriparatide), Xiidra (lifitegrast) and Zemdri (plazomicin) were withdrawn.
The CHMP has also started re-examining ranitidine medicines after the decision to suspend them all in the EU from April 2020.
A detailed report of the meeting outcomes can be found here.