FONT-SIZE Plus   Neg

Chelsea Therapeutics Updates On Northera Regulatory Status, Development Program

Chelsea Therapeutics International Ltd. (CHTP) has received a written response from the U.S. Food and Drug Administration or FDA to its modified proposal for utilizing data from ongoing Study 306B to support its application for marketing approval of Northera in the U.S. In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera Capsules New Drug Application or NDA.

The Advice Letter from the FDA stated "if an analysis of all subjects enrolled in study 306 after [Chelsea] amended the analytic plan demonstrated a statistically significant benefit on the primary endpoint, [FDA] might regard this as a positive trial." However, as this analytic approach seems to exclude at least 109 patients from Study 306B, the FDA further urges that Chelsea 'design and conduct an additional trial to show that droxidopa has a significant and persistent effect' on symptoms of neurogenic orthostatic hypotension.

Based on FDA's feedback, the company is now evaluating several scenarios that may provide the supportive data the FDA is seeking while minimizing any delays to the planned resubmission of its Northera NDA.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
AT&T announced a definitive agreement to purchase Time Warner in a stock-and-cash transaction valued at $107.50 per share. This purchase price implies a total equity value of $85.4 billion and a total transaction value of $108.7 billion, including Time Warner's net debt. AT&T expects the deal to close before year-end 2017. Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator.
comments powered by Disqus
Follow RTT