Mixed Data From Chelsea’s Northera Gets It No Closer To Approval
This article was originally published in Pharmaceutical Approvals Monthly
Chelsea Therapeutics’ latest data release on its late-stage dizziness treatment for Parkinson’s patients raises new questions about the next steps for the drug.
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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.
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.
Two companies in the biopharma space began trading publicly this week, one to pay off debt, the other to fund an early-stage pipeline.