FDA Approval Shouldn’t Be Based On Surrogate Endpoints – Natrecor Article
Executive Summary
The ongoing debate surrounding the safety of Scios' congestive heart failure therapy Natrecor (nesiritide) suggests that FDA should not approve drugs based only on surrogate endpoints, an article published in the July/August 2006 issue of Health Affairs argues
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Dual renin-angiotensin system inhibition is better: Combining Novartis' newly approved direct renin inhibitor Tekturna (aliskiren) with the firm's angiotensin receptor blocker Diovan (valsartan) yields better antihypertensive efficacy than either monotherapy. In a 1,797-patient placebo-controlled study, a combination of aliskiren 300 mg and valsartan 320 mg produces significantly greater blood pressure control rates (49.3% reaching <140/90 mmHg vs. 37.4% for aliskiren, 33.8% for valsartan and 16.5% for placebo), "provides significant additional BP lowering of up to 4.5/3.2 mmHg over [aliskiren] or [valsartan] alone and retains the excellent tolerability of [aliskiren] and [valsartan] monotherapy," the abstract states. Other aliskiren data presented at ACC include an analysis showing BP reductions persisted up to four weeks after discontinuation and a comparative study showing that more patients on Tekturna reached their BP goal than on the ACE inhibitor ramipril (61.4% vs. 53.1%, respectively). Novartis is positioning Tekturna for use in combination therapy, building on its potentially complementary mechanism of action...