The U.S. Food and Drug Administration (FDA) recently
acknowledged the receipt of the New Drug Application (NDA) of
Chelsea Therapeutics International, Ltd.
) Northera. A final decision from the regulatory authority on the
approval of Northera is expected by Feb 14, 2014.
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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
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
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).
Biogen Idec Inc.
Gilead Sciences Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).