Eight medicines set to receive EU approval from CHMP
The European Medicines Committee’s human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications.
Gilead’s remdesivir has been previously recommended for conditional approval for treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. The drug is the first medicine against COVID-19 to be recommended for authorisation in the EU.
The committee has also recommended a conditional marketing authorisation for a conditional marketing authorisation for Hansa Biopharma’s imlifidase, the first treatment for adult patients waiting for a kidney transplant who are highly sensitised against tissue from the donor and have a positive crossmatch test against an available kidney from a deceased donor.
There is an unmet medical need to desensitise these patients and convert a positive crossmatch into negative for them to become eligible for kidney transplantation.
Imlifidase benefited from the support of the PRIME scheme, the Agency’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.
Elsewhere, the committee also backed approvals for:
- Vertex Pharmaceuticals’ Kaftrio (elexacaftor/tezacaftor/ivacaftor), the first triple combination therapy for 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.
- The three biosimilar medicines: Samsung Bioepis’ Aybintio (bevacizumab), for the treatment of various cancers; and Theramex Ireland’s Livogiva (teriparatide) and its duplicate Qutavina (teriparatide), for the treatment of osteoporosis; and
- Two hybrid medicines: Gennisium Pharma’s Gencebok (caffeine citrate), for the treatment of primary apnoea (interruption of breathing) of premature newborns; and Cosmo Technologies’ Methylthioninium chloride Cosmo (methylthioninium chloride), intended as a diagnostic agent to enhance visualisation of colorectal lesions.
However the CHMP took a negative opinion recommending the refusal of a marketing authorisation for Daiichi Sankyo Europe’s Turalio (pexidartinib), which has been developed to treat tenosynovial giant cell tumours.
The Agency voiced concern that although the main study found that tumours shrank in patients treated with Turalio, ‘there was only a small improvement in symptoms such as pain and the ability to use the joint’. Also, it was not clear how long this effect lasts, and there was serious concern about ‘unpredictable, potentially life-threatening effects of Turalio on the liver’.