ESC need-to-know: Xarelto flops, Pfizer’s tafamidis wins, Entresto’s early use and more

Austrian hotel group Vienna House has launched its newest brand, Vienna House R.evo.
The European Society of Cardiology kicked off on Saturday in Munich, as all eyes turned to the cardiovascular data. (Alejandro/CC BY 2.0)

It’s that time of the year, when drugmakers head to the European Society of Cardiology annual conference—the most influential scientific event for cardiovascular medicine on the Continent—in hopes that new data will add heft to their new and forthcoming drugs. And with that new data, analysts and investors are crunching their own numbers, trying to assess how the cardiovascular landscape will change in the coming year.

This meeting's big questions? Whether Pfizer's tafamidis can sweep aside Alnylam's only-just-approved rare disease drug Onpattro, Esperion's cholesterol hopeful bempedoic acid can find a sweet spot and Johnson & Johnson and Bayer's Xarelto can turn trial failures into FDA success. Here's the skinny on those stories and others we're following in Munich.

> Bayer and Johnson & Johnson’s bid to grab even more indications for their blockbuster blood clot fighter Xarelto suffered a double whammy. In a study dubbed Mariner, on more than 12,000 recently hospitalized patients at high risk of developing venous thromboembolism, the drug didn’t top placebo at fending off blood clots or deaths caused by them. And in another trial, Commander HF, the drug failed to improve mortality outcomes in heart failure patients. The data puts a big dent in Xarelto's chances for a big-earning new indication, but J&J says it may find a way to parlay the Mariner data, combined with some earlier trial numbers, into some sort of label expansion. FiercePharma article

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> Pfizer proved its drug tafamidis can reduce the risk of death and cardiovascular-related hospitalizations by about 30% and 32%, respectively, in people with transthyretin amyloid cardiomyopathy (ATTR-CM), a rare condition linked with progressive heart failure. That's a huge win for Pfizer, as cardiologists who talked to Credit Suisse said they’d be pleased with just a 10-15% reduction. The numbers even beat investor hopes for a 20-25% improvement, based on their anticipation of a head-to-head fight against Alnylam, which recently won approval for RNAi drug Onpattro for nerve damage caused by ATTR. Analysts had previously pegged $1 billion for tafamidis annual sales. FierceBiotech article

> Esperion scored a victory as its candidate bempedoic acid, combined with Merck & Co.’s lipid-lowering drug Zetia, lowered bad cholesterol by more than the Merck drug did alone. Esperion is aiming to file for U.S. approval early next year, but safety questions are likely to linger until a closely watched safety trial reports out in October. And if approved? Esperion will have to find a niche somewhere between cheap generic statins and pricey PCSK9 cholesterol-fighers. FierceBiotech article

> Novartis’ now fast-growing heart failure drug Entresto could see more upside as new data showed it can be safely initiated shortly after an acute heart failure. More than half of patients were able to handle the target dose of 200 mg twice daily within 10 weeks of starting treatment, the study found. Meanwhile, Novartis is anticipating an interim analysis from the Paragon-HF trial that compares Entresto to its own Diovan in heart failure patients with preserved ejection fraction. Release

> Long-term use of AstraZeneca’s blood thinner Brilinta as monotherapy after stenting did not reduce the risk of death or heart attack compared with standard dual antiplatelet therapy—aspirin plus a P2Y12 inhibitor—followed by aspirin alone, a study involving more than 15,000 patients showed. Release

> Eisai followed up with details on its outcomes victory that showed its obesity drug Belviq doesn’t increase cardiovascular risks. After the study wrapped, with a median follow-up of 3.3 years, 6.1% of patients in the Belviq arm suffered major cardiovascular events, compared with 6.2% of those on placebo. But while Belviq showed it doesn’t hurt the heart, it couldn’t demonstrate any heart benefits. 11.8% of Belviq patients in the study experienced heart attack, stroke, cardiovascular death, unstable angina, heart failure or coronary revascularization, while 12.1% of those on placebo did—a difference that wasn’t statistically significant. And whether Belviq’s non-inferiority showing helps sales remains to be seen; so far, obesity drugs have floundered in the U.S. market. Release

> Novo Nordisk’s Ozempic reduced the risk of major CV events in people with Type 2 diabetes regardless of previous CV profile, findings from two post-hoc subgroup analyses of the Sustain 6 trial and one in the Sustain 1-5 trials showed. Release

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