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. For more information, see the press release published on 25 June 2020 in the grid below.

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. For more information, see the press release in the grid below.

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. For more information, see the press release in the grid below.

The CHMP recommended granting marketing authorisations for three biosimilar medicinesAybintio (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 medicinesGencebok (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. For more information see the question-and-answer document in the grid below.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for CosentyxEpclusaRemsimaXolair 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). For more information, see the start-of-referral document in the grid below.

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.

Posted on the EMA website on 26 June 2020