The U.S. Food and Drug Administration (FDA) recently acknowledged the receipt of the New Drug Application (NDA) of Chelsea Therapeutics International, Ltd.’s Northera. A final decision from the regulatory authority on the approval of Northera is expected by Feb 14, 2014.
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.
In Jul 2013, Chelsea Therapeutics resubmitted the NDA for Northera for this indication and was accepted by the U.S. regulatory body a few days later. However, the FDA later informed the company of deficiencies in the NDA regarding the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings.
Last month Chelsea Therapeutics submitted additional information to the FDA to resolve certain technical deficiencies in its NDA. Following, the submission of the additional information, the U.S. regulatory body acknowledged it as a complete response to the complete response letter (CRL) issued by it in Mar 2012. The CRL was issued in response to the NDA filed by the company in Sep 2011.
We note that Northera enjoys both orphan drug designation and fast track designation in the U.S.
While issuing the CRL, the FDA asked for data from an additional study to support efficacy of the candidate. The company was also asked to design a study, which would demonstrate durability of effect over a 2- to 3-month period.
We expect investor focus to remain on the FDA’s decision on Northera. The successful development and subsequent commercialization of Northera will be a major milestone for Chelsea Therapeutics, which currently does not have any marketed product in its portfolio.
Chelsea Therapeutics currently carries a Zacks Rank #3 (Hold). Right now, Actelion Ltd. , Biogen Idec Inc. (BIIB - Free Report) and Gilead Sciences Inc. (GILD - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).