Chelsea Therapeutics International, Ltd.
) announced that the Cardiovascular and Renal Drug Advisory
Committee (CRDAC) of the U.S. Food and Drug Administration (FDA)
recommended (16-1) in favor of aprpoving Northera.
The company 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
A final decision from the FDA is expected to be out by Feb14,
2014. We note that although the FDA is not bound to accept the
recommendation of the panel, it usually considers the same while
deciding on the fate of a drug.
We remind investors that this is not the first time that Northera
has received a positive opinion from the CRDAC. In Feb 2012, the
CRDAC had voted 7-4 recommending approval of Northera for the
above mentioned indication.
However, the FDA issued a complete response letter for the
candidate in Mar 2012. The FDA had asked the company to submit
positive data from an additional study supporting the efficacy of
the candidate. The agency also recommended that the study should
be designed to show durability of effect over a time period of
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We note that Northera enjoys both orphan drug designation and
fast track designation in the U.S.
Chelsea Therapeutics shares had nosedived 29.2% last week ahead
of the FDA panel as investors anticipated a negative
recommendation based on the FDA's briefing document. But, with
the panel voting in favor of approval, we expect the price to
rise significantly. However, we advise investors to remain
cautious given the bumpy history of Northera and mixed comments
related to the drug's long-term efficacy in the FDA's briefing
Chelsea Therapeutics currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks include
Impax Laboratories Inc.
). All three carry a Zacks Rank #1 (Strong Buy).