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GSK Goes To The Heart Of The Problem With Outcomes Study For Darapladib

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline is applying a lesson the pharmaceutical industry learned from recent events in cardiovascular drug development: do an outcomes study, and start it early

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Targeting Inflammation In Atherosclerosis After Darapladib: Does The IL-6 Pathway Hold The Answer?

Targeting inflammation appears to be a promising complementary approach to lipid-lowering drugs in atherosclerosis, but the question of which pathway in a complex system to target remains open. The failure of GlaxoSmithKline’s darapladib in the STABILITY trial may have dealt a fatal blow to phospholipase A2 enzymes as targets, but the interleukin-6 pathway is gaining attention with the ongoing CANTOS study of Novartis’ canakinumab and the NHLBI’s CIRT study of low-dose methotrexate.

R&D, In Brief

GSK starts second darapladib Phase III study: GlaxoSmithKline's second Phase III trial of its Lp-PLA2 inhibitor darapladib will evaluate long-term treatment with the first-in-class agent, which targets an enzyme linked to atherosclerotic plaque. The SOLID-TIMI 52 (Stabilization of Plaque using Darapladib-Thrombolysis in Myocardial Infarction) study started enrolling 11,500 patients with acute coronary syndrome, the firm announced Dec. 9. Darapladib, in combination with standard of care (which may include a statin, aspirin and blood pressure medications) will be compared to placebo, to assess the impact on cardiovascular events after starting treatment within 30 days of an ACS. The company started its first Phase III trial for the anti-atherosclerosis medication in late 2008, the 15,000-patient STABILITY trial in patients with chronic coronary artery disease is also tracking major cardiovascular events. With the darapladib clinical program, GSK has opted to conduct outcomes trials for the registrational studies, acknowledging the regulatory reality that particularly in the cardiovascular setting, FDA favors the more definitive morbidity and mortality data - as opposed to evidence of effect on surrogate endpoints - for its approval decisions (1Pharmaceutical Approvals Monthly, January 2009). The first trial is projected to report out in late 2011, although as an event-driven trial the timeline is uncertain. GSK reports that STABILITY completed patient enrollment ahead of schedule, and in October the firm announced that the trial had passed an interim safety analysis, primarily concerned with blood pressure effects

R&D, In Brief

GSK starts second darapladib Phase III study: GlaxoSmithKline's second Phase III trial of its Lp-PLA2 inhibitor darapladib will evaluate long-term treatment with the first-in-class agent, which targets an enzyme linked to atherosclerotic plaque. The SOLID-TIMI 52 (Stabilization of Plaque using Darapladib-Thrombolysis in Myocardial Infarction) study started enrolling 11,500 patients with acute coronary syndrome, the firm announced Dec. 9. Darapladib, in combination with standard of care (which may include a statin, aspirin and blood pressure medications) will be compared to placebo, to assess the impact on cardiovascular events after starting treatment within 30 days of an ACS. The company started its first Phase III trial for the anti-atherosclerosis medication in late 2008, the 15,000-patient STABILITY trial in patients with chronic coronary artery disease is also tracking major cardiovascular events. With the darapladib clinical program, GSK has opted to conduct outcomes trials for the registrational studies, acknowledging the regulatory reality that particularly in the cardiovascular setting, FDA favors the more definitive morbidity and mortality data - as opposed to evidence of effect on surrogate endpoints - for its approval decisions (1Pharmaceutical Approvals Monthly, January 2009). The first trial is projected to report out in late 2011, although as an event-driven trial the timeline is uncertain. GSK reports that STABILITY completed patient enrollment ahead of schedule, and in October the firm announced that the trial had passed an interim safety analysis, primarily concerned with blood pressure effects

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