EMA/CHMP recommends four new medicines and one generic for approval

Following its July 22-25 meetings, today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) it has recommended four novel medicines for approval.

The Committee recommended granting a conditional marketing authorization for German drug major Bayer’s (BAYN: DE) Vitrakvi (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. NTRK gene fusions occur very frequently in a number of rare cancers.

The CHMP granted a positive opinion for GW Pharmaceuticals’ (Nasdaq: GWPH) Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy. Epidyolex contains an actibe substance derived from cannabis and is the first to receive a positive opinion in the EU centralized procedure. The CHMP’s positive opinion is based on results from four randomised, controlled Phase III trials.