EMA's CHMP recommends approving a bunch of novel and biosimilar drugs

At its June meeting, the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) issued positive opinions on a number of new medicines as well as biosimilars. The opinions will now be sent to the European Commission for the adoption of a decision, which normally takes two to three months

The Committee recommended granting a conditional marketing authorization for Gilead Sciences Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen, which was fully reported yesterday.

The CHMP recommended granting a conditional marketing authorization for Swedish firm Hansa Biopharma’s Idefirix (imlifidase), the first treatment for adult patients waiting for a kidney transplant who are highly sensitized 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, the EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.