Positive EU recommendations for Kigabeq, Slenyto and Onpattro

28 July 2018

At its July meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a total of 16 medicines (see separate story for more), with the most significant developments being the following.

The CHMP has recommended granting two new pediatric-use marketing authorizations (PUMAs), for Kigabeq (vigabatrin), from Lundbeck (LUND: CO), and Slenyto (melatonin), from Neurim Pharmaceuticals.

PUMAs can be granted for authorized medicines which have been developed specifically for children and are no longer under patent protection. PUMAs aim to stimulate research of existing medicines for better treatments for children by giving the medicines ten years of market protection.

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