Acceptability Of Revised Study Expected To Be On Agenda For Northera Advisory Panel
This article was originally published in The Pink Sheet Daily
Chelsea would address duration of effect questions for the neurogenic orthostatic hypotension drug with a post-approval study.
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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.
Not The Next Avastin? Plan For New ProAmatine Studies Would Negate Shire’s Withdrawal Hearing Request
A joint proposal from CDER and Shire calling for two new studies to verify clinical benefit of the hypotension agent would negate the need for a hearing on CDER’s proposed withdrawal, if Commissioner Hamburg accepts it.