Not all drugs that are reviewed under the European Medicines Agency’s accelerated assessment pathway go on to receive a timely marketing authorization decision. A case in point is Santen's orphan drug Verkazia (ciclosporin) for treating the rare and severe eye condition vernal keratoconjunctivitis (VKC) in children from four years of age and in adolescents.
Santen’s EU marketing authorization application (MAA) for Verkazia received a positive opinion from the EMA's human medicines scientific committee,...