Chelsea Therapeutics International Ltd.
) gained accelerated approval from the U.S. Food and Drug
Administration (FDA) for Northera for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH). Chelsea
Therapeutics expects to launch Northera in the second half of
The approval was granted under the FDA's accelerated approval
program, which allows conditional approval of a drug for an unmet
medical condition, provided additional studies are conducted.
However, Chelsea Therapeutics still needs to assess the
continued efficacy of Northera in patients as the effectiveness
of Northera beyond two weeks has not yet been demonstrated.
Hence, a multi-center, placebo-controlled, randomized study has
been preliminarily agreed upon between the company and the FDA.
This study is designed to establish the durability of the
clinical benefits of Northera.
Northera was initially developed by Dainippon Sumitomo Pharma
Co., Ltd. In 2006, Chelsea Therapeutics acquired global
development and commercialization rights to Northera from
Dainippon, excluding Japan, Korea, China and Taiwan.
We note that the approval path in the U.S. for the drug has
been far from smooth. The first New Drug Application (NDA) for
Northera was filed in Sep 2011. A complete response letter (CRL)
was issued in response to the NDA in Mar 2012.
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 CRL issued by it in Mar
The NDA (including the resubmission), included data from study
301, study 306B, study 302, study 303, study 306A, two long-term
open label extension studies, a dedicated thorough QTc study and
a 24-hour ambulatory blood pressure monitoring study.
Chelsea Therapeutics carries a Zacks Rank #3 (Hold). The
successful commercialization of Northera will be a major
milestone for Chelsea Therapeutics, which currently does not have
any marketed product in its portfolio.
We expect investors to react positively to the approval news.
The stock is up in pre-market trading. Investors looking for
better-ranked stocks in the biopharma sector may consider
Biogen Idec Inc.
). Endocyte and Biogen carry a Zacks Rank #1 (Strong Buy) while
Actelion carries a Zacks Rank #2 (Buy).
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