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Amarantus requests rare pediatric disease designation from US FDA for MANF

 

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Amarantus Bioscience Holdings Inc. a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF(mesencephalic-astrocyte-derived neurotrophic factor). MANF was previously granted orphan drug designation (ODD) by the US FDA in December 2014.

In December 2015, Amarantus submitted ODD and RPDD applications to the US FDA for engineered skin substitute in the treatment of Giant Congenital Hairy Nevus (GCMN), in addition to its ODD application to the US FDA for eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID) submitted in October 2015.

The Company expects to receive responses regarding these designation applications in the first quarter of 2016.

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