Six new medicines backed for approval by EMA's CHMP

The European Medicines Agency’s EMA’s human medicines committee (CHMP) has recommended six medicines, three of which are novel drugs, for approval at its February 2021 meeting.

The Committee recommended granting a marketing authorization for Evrysdi (risdiplam), from Swiss pharma giant Roche (ROG: SIX), the first treatment that can be given orally to patients with certain types of spinal muscular atrophy, a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Since Evrysdi addresses an unmet medical need, it benefited from support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. Evrysdi was reviewed under EMA’s accelerated assessment program.

The CHMP recommended granting a conditional marketing authorization for Jemperli (dostarlimab), from the UK’s GlaxoSmithKline (LSE: GSK), for the treatment of certain types of recurrent or advanced endometrial cancer. The application is based on data from the GARNET study, which represents the largest dataset of an anti-PD-1 monotherapy treatment in endometrial cancer.