Last summer Chelsea Therapeutics ($CHTP) did some painful belt tightening after its stock price plunged following the FDA's decision to reject its application for Northera (droxidopa), saying the biotech would have to pull off another study of its experimental drug before it could win an OK. But today's news that the agency would accept a resubmission based on data for the drug from an earlier study triggered a festive response from investors, who quickly bid up shares by more than 100%.
After a successful FDA appeal, Chelsea says it now plans to resubmit its application for the treatment--designed to prevent dizziness and fainting among patients with disorders of the nervous system--in the second quarter. But an approval is not certain.
Chelsea will now push ahead with data from their 306B study, as the biotech says that the FDA guidance suggests that the short-term benefits seen in that trial warrant a second look. In the study, patients demonstrated a significant response at week one, but then failed to post a statistically significant long-term improvement. A post-approval study, though, could be used to test the treatment's efficacy over a prolonged period.
In its release, Chelsea noted: The FDA guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval."
"We appreciate and are encouraged by FDA's willingness to consider data from Study 306B in evaluating Northera for the treatment of NOH, and look forward to submitting the totality of our clinical experience to date to the Agency for review," said Joseph G. Oliveto, the interim chief executive officer of Chelsea. "We now have a regulatory path forward, including the potential for an approval of Northera later this year."
- here's the release
- read the Reuters story
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