Chelsea’s Hypotension Drug Droxidopa Could Fill Void If FDA Pulls ProAmatine
Executive Summary
The regulatory uncertainty surrounding Shire’s hypotension drug midodrine (ProAmatine and generics) leaves Chelsea Therapeutics International Ltd. in a good position for its newly submitted Northera (droxidopa).
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FDA Panel Will Weigh Northera’s Short-Term Benefit Vs. Lack Of Durable Effect, Safety Concerns
At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.
Chelsea Therapeutics’ Northera Advisory Review May Turn On Validity Of Combined Clinical Trial Analysis
Only one of two pivotal Phase III clinical trials of Chelsea Therapeutics’ Northera (droxidopa) for symptomatic neurogenic orthostatic hypotension showed significant results, but a combined analysis of both trials ascribes major improvement on three separate scores for subjects in the active arm.
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.