Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting.
The Committee recommended granting a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.
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, 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 recommended granting marketing authorisations for 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.
Negative opinion on a new medicine
The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Turalio (pexidartinib). Turalio was expected to be used to treat tenosynovial giant cell tumours.
Five recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Cosentyx, Epclusa, Remsima, Xolair and Zavicefta.
Start of referral
The Committee started a review of the vaccine Varilrix, (live attenuated varicella virus (OKA strain)) to harmonise the way it is used in the countries where it is available the EU. Varilrix is used for protecting individuals against varicella (chickenpox).
Start of re-examination of recommendation on ranitidine medicines
Following the CHMP’s recommendation of April 2020 to suspend all ranitidine medicines in the EU, one of the marketing authorisation holders involved with this review has requested a re-examination. Upon receipt of the grounds for the request, the CHMP will start a re-examination and issue its final recommendation.
Withdrawals of applications
Applications for initial marketing authorisations for Sondelbay (teriparatide), Xiidra (lifitegrast) and Zemdri (plazomicin) have been withdrawn.
Sondelbay was expected to be used to treat osteoporosis. Xiidra was intended for the treatment of dry eye disease. Zemdri was intended for the treatment of complicated urinary tract infection.
* These products were designated as an orphan medicines during their development. Orphan designations are reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicines’ orphan status and granting the medicines ten years of market exclusivity