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Eight Months And Counting: Santen Still Waiting For Final Marketing Decision On Drug Fast-Tracked By EMA

 
• By Vibha Sharma

It has been eight months since the European Medicines Agency recommended market approval for a drug that was reviewed under its fast-track mechanism, but the sponsor has yet to receive a final decision from the European Commission. The company ran into problems when seeking to renew the drug's orphan status before approval.

Praying
Commission's decision-making process regarding Verkazia is still ongoing • Source: Shutterstock

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,...

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