Chelsea Therapeutics International, Ltd.
) announced that the Cardiovascular and Renal Drug Advisory
Committee of the U.S. Food and Drug Administration (FDA) will
review the New Drug Application (NDA) filed for Northera in Jul
2013. The meeting is scheduled to take place on Jan 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).
The FDA's decision on the approval of Northera is expected by Feb
14, 2014. We note that Northera enjoys both orphan drug
designation and fast track designation in the U.S.
After the NDA was resubmitted in Jul 2013, the FDA had
informed Chelsea Therapeutics 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.
In Aug 2013, Chelsea Therapeutics had submitted additional
information to the FDA to resolve certain technical deficiencies
in the 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.
Chelsea Therapeutics currently carries a Zacks Rank #2 (Buy).
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. Currently, companies like
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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