Eight medicines recommended for approval in EU; use of Truvada extended

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its July meeting.

The Committee recommended granting a pediatric use marketing authorization (PUMA) for Sialanar (glycopyrronium bromide), from privately-held UK firm Proveca, to treat severe drooling in children and adolescents with neurological disorders. This followed a re-examination of the Committee’s earlier negative opinion. PUMAs can be granted for medicines which are already authorized, but no longer under patent protection, and that have been developed specifically for children. This is the third time that the Committee has recommended a PUMA since the introduction of this type of marketing authorization by the Pediatric Regulation, which came into force in 2007.

The CHMP recommended granting a marketing authorization for the orphan medicine Onivyde (irinotecan), from Ireland-headquartered Sire (LSE: SHP) for the treatment of metastatic adenocarcinoma of the pancreas.