Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data
This article was originally published in Pharmaceutical Approvals Monthly
Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.
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In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.