Results from the Phase III COMPASS trial presented at the European Society of Cardiology (ESC) congress showed that use of Johnson & Johnson and Bayer's Xarelto (rivaroxaban) plus aspirin reduced the risk of major cardiovascular (CV) events by a significant 24 percent in patients with stable coronary and/or peripheral artery disease (CAD/PAD), compared to aspirin alone, the companies announced Sunday. Credit Suisse analyst Divan Vamil has suggested that a positive result in the trial could increase sales of the Factor Xa inhibitor by $1.5 billion in the US alone.
In the study, investigators randomised 27 395 patients with stable CAD and/or PAD to receive a regimen consisting of 2.5-mg of Xarelto twice-daily plus aspirin once daily, 5 mg of Xarelto twice daily, or aspirin once daily.
Results, which were published in the NEJM, showed that in addition to meeting the primary efficacy endpoint of reducing major CV events, the combination of low-dose Xarelto and aspirin specifically cut the risk of any stroke by 42 percent, heart attack by 14 percent and CV deaths by 22 percent, compared with aspirin alone. Further, Xarelto plus aspirin also lowered the combined secondary endpoint of coronary heart disease death, heart attack, ischaemic stroke and acute limb ischaemia by 28 percent compared to aspirin alone.
Johnson & Johnson said a significantly higher proportion of patients in the combination group experienced major bleeding compared with those given aspirin alone, at 3.1 percent and 1.9 percent, respectively. "This was mainly due to an increase in bleeding leading to hospitalisation, with most bleeding occurring in the gastrointestinal tract," the company noted, adding that there was no significant difference in fatal bleeds and intracranial bleeds. "In total, the benefits outweigh the side-effect risks by far," commented Frank Misselwitz, head of cardiovascular drug development at Bayer, "you can see it from the clearly lowered mortality rate and that number also takes the cases of fatal bleeding into account."
Meanwhile, Peter DiBattiste, Johnson & Johnson's global head of cardiovascular R&D, stated that the company plans to seek FDA approval for the new use, including the approval of a new 2.5-mg dose of Xarelto, by the end of the year.
Xarelto is already cleared for multiple indications, including preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation in both the US and Europe. Bayer indicated that, if approved, Xarelto may potentially be used on 30 million additional patients in its largest national markets, on top of a population of approximately 25 million patients in atrial fibrillation. The drug generated 2.9 billion euros ($3.5 billion) in sales for Bayer last year, while partner Johnson & Johnson, which gets a majority of US revenues, recorded sales of $2.3 billion.
For related analysis, see KOL Views: Leading haematologist says COMPASS could be massive boost for Bayer, Johnson & Johnson's Xarelto.
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