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 2014.
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 2012.
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 companies like Endocyte Inc (ECYT - Free Report) , Actelion Ltd. (ALIOF - Free Report) and Biogen Idec Inc. (BIIB - Free Report) . Endocyte and Biogen carry a Zacks Rank #1 (Strong Buy) while Actelion carries a Zacks Rank #2 (Buy).