A Close Call: FDA’s Decision Memo On The Approval of Chelsea Therapeutics’ Northera
On February 18, FDA granted accelerated approval to Chelsea Therapeutics’ Northera (droxidopa) for neurogenic orthostatic hypotension. The review was difficult, generating a “complete response” letter and a formal dispute resolution after the first cycle, and a negative primary review on the second go-around. The final decision by Office of Drug Evaluation I Director Ellis Unger was to overrule the division director and approve the application. His approval memo stands out for its detailed analysis of the arguments “pro” and “con,” and ultimately as a statement in support of extra flexibility for rare disease drugs. Here is the conclusion of his memo.
Dr. Targum, the cross-discipline team leader, provided a superb summary of the evidence of effectiveness, and her views are summarized as follows:
The applicant submitted 4 studies in the NDA: 301, 302, 303, and 306B. Two of them, Studies 301 and 306B, were positive. Although Studies 301, 302, and 303 were enriched,...
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