You missed the American College of Cardiology meeting. That's OK. The most newsworthy research coming out of the meeting is gathered right here, with almost every Big Pharma in attendance.
- Eli Lilly & Co. ($LLY) unveiled full data from the cholesterol drug study that disappointed so many last October--not only Merck ($MRK), also developing a CETP class med, but PCSK9 drugmakers Regeneron ($REGN), Sanofi ($SNY) and Amgen ($AMGN). Evacetrapib failed to beat placebo at preventing CV events, despite delivering big LDL cholesterol cuts and even bigger increases in HDL, and as Bernstein analyst Tim Anderson notes, evacetrapib's CV event figures over time tracked almost exactly in line with placebo's. Report
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If the CETP trial results raise new questions about the benefits of lowering LDL in general, then new data on AstraZeneca's ($AZN) Crestor adds to the case for lowering cholesterol with statin meds. In the global study, also published in the New England Journal of Medicine, patients on the lower end of the heart-risk scale took either statin meds, blood pressure meds, a combination of both, or placebo. The Crestor patients saw a 25% reduction in risk of CV events compared with placebo, with similar results in the combo group, suggesting the benefits came from the statin med, the study authors said. As Cardiobrief also notes, this looks good for statins but not so great for anti-hypertensives. Study | Post - Meanwhile, a JAMA article backed PCSK9 drugs for high-risk patients truly intolerant to statins, based on data from the GAUSS trial released at ACC. The trial tested Amgen's Repatha (evolocumab) and Merck's ($MRK) Zetia (ezetimibe), which uses a different mechanism of action. Repatha delivered LDL-lowering benefits about three times larger than Zetia did. Still, the article noted PCSK9 meds' pricing--about $14,000 per year--as a deterrent, as well as a lack of outcomes data. The drugs aren't currently approved for statin-intolerant patients. Article | Story
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Novartis ($NVS) trotted out new Entresto analyses showing that the drug helps heart failure patients who are stable, in addition to those who aren't. More important to Entresto's commercial case: Numbers showing both groups of Entresto patients were less likely to die or need hospital care than those taking another standard therapy, enalapril. Novartis needs all the help it can get to jump-start Entresto's slow launch, which has so far fallen far short of high expectations. Release - Johnson & Johnson's ($JNJ) Janssen unit delivered the latest data from an ongoing outcomes study of its anticoagulant med Xarelto. The real-world data turned up side effects in line with those in clinical trials supporting its approval, and confirmed its safety in diabetes patients, the company said. Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) rolled out new clinical data and real-world analyses on their competitor med Eliquis, 17 in all. And Boehringer Ingelheim, which makes another rival drug, Pradaxa, released new data on its antidote--to be used in case of bleeding--that showed the drug worked in emergency situations. Release | Release | Release
- Pfizer's late-to-the-party PCSK9 drug bococizumab racked up solid late-stage data in a second late-stage study, beating placebo at lowering LDL cholesterol over 12 weeks of therapy. Detailed results aren't yet available. Pfizer is counting on outcomes data to help bococizumab gain a foothold against recently launched PCSK9 meds Praluent and Repatha. Release
- New ACC/American Heart Association treatment guidelines gave AstraZeneca's ($AZN) Brilinta a boost by placing it ahead of the standard med clopidogrel, aka Plavix, in certain patients with acute coronary syndromes. Brilinta also was recommended for longer-term use, based on a new FDA approval. Lilly's Effient also got clopidogrel-beating placement in the guidelines for some patients. Report | Release
Special Report: The top 20 drugs in 2020 by worldwide sales - Entresto