Hypertension Drug Labeling Would Benefit From Responder Analysis
Advisory committee members say they’d feel better about approving combo products for hypertension if labeling included pivotal trial data enabling clinicians to assess how individual patients fared on therapy.
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FDA’s Cardiovascular and Renal Drugs Advisory Committee used much of its review of a nebivolol/valsartan combo pill to discuss how much of an improvement a “me-too” product should offer over predecessors and a minimum clinical benefit threshold for antihypertensives.
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.
The January 2010 approval for Acorda Therapeutics Inc.'s oral multiple sclerosis therapy Ampyra (dalfampridine) is an impressive accomplishment - by any account. The company took a drug that failed one development program and resurrected it so that it ultimately won FDA approval and is fast becoming a commercial success. Every drug and indication has its challenges, and gaining FDA approval is never simple. But Acorda's challenges were greater than most. MS causes demyelination, which leads to slower nerve conduction; gait problems are one of its most common symptoms. Acorda was first to tackle the walking problem, and it faced the challenge of proving a novel benefit in a disease that is highly debilitating, progressive, and variable. Patients can feel better one day, worse another, for reasons no one entirely understands, making it difficult to discern a drug's impact. Along the way, Acorda also had to contend with the usual complications: development setbacks, edgy investors and negotiations with FDA. To demonstrate that its new drug for walking impairment was efficacious, Acorda devised an innovative responder rate analysis, which used a novel endpoint and an unusual statistical analysis to identify subsets of responders.