Vanda Pharmaceuticals Inc. (Vanda), a biopharmaceutical company focused on the development and commercialization of products for the treatment of CNS disorders, held a pre-NDA meeting with the Division of Neurology Products of the US Food and Drug Administration (FDA) to discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24.
At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology programme, chemistry and manufacturing was also deemed adequate to support filing.
"We are pleased with the positive interaction we had with the FDA as we are moving closer to providing a treatment for blind individuals with Non-24," said Mihael H. Polymeropoulos, president and CEO of Vanda.
Based on this successful completion of the pre-NDA meeting, Vanda is targeting an NDA submission for tasimelteon in mid-2013.