Analysts expressed mixed reactions Monday to study results presented at the American Heart Association Scientific Sessions showing that adding low doses of Johnson & Johnson and Bayer's Xarelto (rivaroxaban) to standard therapy significantly prevented the occurrence of secondary cardiovascular events in patients with acute coronary syndrome (ACS), compared with standard therapy alone.
Leerink Swann analyst Seamus Fernandez remarked that "Xarelto appears to have hit the 'sweet spot' for efficacy with an acceptable safety profile." He suggested that the market for drugs to treat ACS is likely to exceed $1 billion, and Johnson & Johnson and Bayer's product could "be a meaningful competitor in an increasingly crowded space that has been relatively slow to develop commercially." He predicted that the low dose of the drug investigated in the late-stage ATLAS ACS 2 TIMI 51 trial would win FDA approval.
Results showed that in patients who took the low dose of the drug twice daily, the risk of cardiovascular death was reduced by 34 percent, compared to standard therapy. Although data also indicated that Xarelto significantly increased the rate of major bleeding, the drug wasn't associated with an excess risk of fatal bleeding over standard therapy alone. "This will make Xarelto a must-have drug for cardiologists for at least a proportion of their acute coronary syndrome patients," UniCredit analysts Craig Maxwell and Andreas Heine said.
However, analysts at Deutsche Bank said they expected Xarelto's "use in ACS to be limited, given the availability of newer, more potent antiplatelet regimes," including AstraZeneca's Brilinta (ticagrelor), which they noted "improve outcomes with less increased bleeding." Along with Brilinta, Eli Lilly's Effient (prasugrel) is approved to treat patients with ACS, with both drugs being used instead of standard treatment with Bristol-Myers Squibb and Sanofi's Plavix (clopidogrel). Xarelto will likely be used in combination with Plavix. "The initial commercial potential [of Xarelto] looks limited, given the increased bleeding risks seen with Xarelto in the trial," the Deutsche Bank analysts remarked.
The UniCredit analysts also noted that the study results "combined with the failure of key competitor Eliquis in the prevention of venous clots presented in the same meeting, will in our view drive a significant sentiment swing in favour of Xarelto among cardiologists." Data presented at the conference showed that Pfizer and Bristol-Myers Squibb's Eliquis (apixaban) failed to significantly prevent venous thromboembolism in patients with acute medical illness, compared with Sanofi's Lovenox (enoxaparin).
Johnson & Johnson and Bayer plan to file for approval of Xarelto in the US and Europe for use in patients with ACS by the end of the year. The drug is already authorised by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery.
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