EMA/CHMP recommends eight new drugs for approval, including five orphans
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its July meeting, and rejected two.
The CHMP recommended granting a marketing authorization for Japanese drugmaker Santen’s (TYO: 4536) Verkazia (ciclosporin), an orphan medicine to treat severe vernal keratoconjunctivitis in children and adolescents. This medicine was reviewed under EMA’s accelerated assessment mechanism. There is a need for additional treatments because currently authorised therapies are not always effective or adequate to control severe VKC, the CHMP noted.
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