Europe – 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…