Eight medicines leap towards EU approval

The European Medicines Committee's human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications.

As PharmaTimes previously reported, Gilead's Veklury (remdesivir) has been 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 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.

Highly sensitised patients have exceptionally high antibody levels that react to the donor’s tissue which shows up as a positive crossmatch test, making it more likely that the body will reject the donor organ, and this leaving patients unable to receive a transplant.

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.

Idefirix is made of an enzyme derived from the bacterium Streptococcus pyogenes, which breaks down antibodies called immunoglobulins G (IgG). IgG is produced by the patient against the transplanted organ. By breaking down IgG, the medicine is expected to prevent the patient's immune system from attacking the newly transplanted organ, thereby reducing the risk that the organ will be rejected, the EMA noted.

Idefirix 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. Kaftrio will provide a new therapeutic option for many cystic fibrosis patients, including those with MF mutations where no treatment exists, if approved by the EMA;

• 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.

On the down side, the CHMP adopted 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'.