Vanda Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder in totally blind individuals. If approved it will be the first FDA approved treatment for Non-24.
Vanda previously announced that during a pre-NDA meeting, that the efficacy, safety and supporting data package proposed to be included in the NDA would be adequate to support filing the NDA for review by the FDA. The tasimelteon Non-24 NDA includes data from the largest clinical program conducted to date for any investigational therapy for the treatment of Non-24.
Tasimelteon is a dual melatonin agonist (DMRA) with selective agonist activity at MT1 and MT2 receptors. It has the ability to reset the master body clock in the suprachiasmatic nucleus, resulting in the entrainment of the body’s melatonin and cortisol rhythms to align to the 24-hour day-night cycle.
For more information call (240) 599-4500 or visit www.vandapharma.com.