Chelsea Therapeutics International Ltd. recently announced that the US Food and Drug Administration (FDA) has accepted new drug application (NDA) resubmitted by the company for its pipeline candidate, Northera (droxidopa).
Chelsea Therapeutics is looking to get Northera approved for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Results from a large phase III study (306 B) demonstrating improvement in dizziness / lightheadness, the main symptom of NOH and confirming findings from the previous 301 study, was included in the resubmitted NDA. A final decision from the FDA is expected by Jan 3, 2014 (target date).
Chelsea Therapeutics had initially submitted an NDA for Northera in Sep 2011. However, the company received a complete response letter (CRL) in Mar 2012. In the CRL, the FDA asked Chelsea Therapeutics to conduct and submit data from an additional positive study supporting efficacy in the 301 study. The company was also asked to design a study which would demonstrate durability of effect over a 2- to 3-month period.
In the CRL, the FDA also mentioned an additional bioequivalence study for the approval of Northera 300 mg capsules. Chelsea Therapeutics was considering making these capsules commercially available to complement the 100 mg and 200 mg capsules which were being utilized in the clinical program..
Taking note of this, Chelsea Therapeutics included a bioequivalence study for the 300 mg dose in the resubmitted NDA. We believe investor focus will remain on the FDA decision on Northera.
Chelsea Therapeutics carries a Zacks Rank #4 (Sell).Right now, Jazz Pharmaceuticals plc (JAZZ - Analyst Report) carriesa Zacks Rank #1 (Strong Buy). Vertex Pharmaceuticals Inc. (VRTX - Analyst Report) and Santarus, Inc. also look attractive with a ZacksRank #2 (Buy).