FDA Committee recommends approval of Chelsea drug Northern

Source: Biovalley 2014-1-16 Chelsea pharmaceutical announced on January 15 that FDA's cardiovascular and renal Drugs Advisory Committee (crdac) proposed to approve the company's drug, northern (droxidopa), with a vote of 16 to 1 For the treatment of symptomatic neurogenic postural hypotension (Noh) in patients with primary autonomic neurasthenia (Parkinson's disease, multiple system atrophy and pure autonomic neurasthenia), dopamine β - hydroxylase deficiency, nondiabetic autonomic neuropathy, etc On November 11, FDA internal reviewers concluded that a batch of new data submitted by Chelsea pharmaceutical was not enough to support the approval of northern, and suggested that FDA cardiovascular and renal drug advisory committee vote to reject the approval of the drug FDA is not bound by crdac's recommendations, but will take them into consideration when reviewing northern drug application (NDA), whose PDUFA target date is February 14, 2014 Previously, the FDA has granted northern orphan drug status and entered the FDA's special fast track The purpose of the special fast track is to speed up the review of medicines that have not yet met medical needs for the treatment of serious or potentially life-threatening diseases About Northern A: Northern A is the main research drug of Chelsea pharmaceutical, currently in clinical phase III, which is developed for the treatment of symptomatic neurogenic orthostatic hypotension (Noh) in patients with primary autonomic neurasthenia (such as Parkinson's disease, multiple system atrophy and simple autonomic neurasthenia) Droxidopa is a synthetic catecholamine, which is directly converted to noradrenaline by decarboxylation, which increases the level of noradrenaline in central and peripheral nervous system.