Neuren Pharmaceuticals Limited
(ASX:NEU) has taken another important step in the US with its breakthrough drug for brain injuries.
Neuren has applied to the US Food and Drug Administration for Orphan Drug designation and Breakthrough Therapy designation for its NNZ-2566 treatment in Rett Syndrome.
Orphan Drug is granted to drugs that treat rare conditions and qualifies for seven years of marketing exclusivity and the waiving of marketing fees. This designation has already been granted to Neuren for NNZ-2566 in the treatment of Fragile X syndrome.
Breakthrough Therapy streamlines the development process of new medicines that demonstrate improvement over existing therapies.
Phase 2 clinical trials have shown positive results for Neuren’s treatment for Rett Syndrome and the bio company hopes to move the drug through development and marketing approval as quickly as possible.
Neuren Pharmaceuticals Limited
(ASX:NEU) made a net loss of $4.7 million for the 2014 financial year.
