NeuroVive Pharmaceutical AB has announced that the European Commission has granted orphan drug designation (ODD) for the company’s KL1333 programme for oral treatment of the genetic mitochondrial disease Mitochondrial Myopathy, Encephalopathy, Lactic acidosis and Stroke-like episodes (MELAS).
he decision by the Commission confirms the opinion previously issued by the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), which was communicated by NeuroVive on 8 November 2017. The orphan drug designation for KL1333, together with NeuroVive’s status as a micro, small and medium-sized enterprise (SME), offers NeuroVive access to free scientific advice (protocol assistance) from the EMA, as well as fee reductions and further administrative assistance from EMA’s SME office. If approved for orphan drug status when authorized for marketing, KL1333 would benefit from ten years of market exclusivity within the European Union.
KL1333 is being developed jointly by NeuroVive and the Korean pharmaceutical company Yungjin Pharm. KL1333 has shown promising results in preclinical models and a clinical phase I study is currently being conducted in Korea. NeuroVive plans to initiate the next clinical phase I study in 2018.
Neurovive’s, programme, european orphan drug designation
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