Bayer has suffered a setback after advisors to the US Food and Drug Administration narrowly voted against expanding the label on its Johnson & Johnson-partnered anticoagulant Xarelto.
The agency’s Cardiovascular and Renal Drugs Advisory Committee voted 6-4 (with one abstention) against the approval of Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The FDA is not bound to follow the panel's advice, although it usually does, and a final decision is expected by June 29.
The vote comes as a bit of a surprise, given that earlier this week, FDA reviewer Karen Hicks had recommended approval for the ACS indication, due to a reduction in cardiovascular death. However, she highlighted the increased risk of major and fatal bleeding, saying this "may represent the biggest problem for both patients and health care providers".
Her observations have proved correct in terms of the panel's stance, as committee members expressed concerns about bleeding side effects. They were also concerned that over 15% of participants enrolled in the 15,00-patient ACS study dropped out.
Kemal Malik, head of global development at Bayer Healthcare, said that "we appreciate the thoroughness of the committee", adding that together with J&J, "we will ensure that the questions raised are addressed so the FDA may finalise their review". Xarelto is already approved in the USA for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to prevent venous thromboembolism in patients undergoing knee or hip surgery.
Regorafenib filed in USA and Europe
Meantime, Bayer also revealed that it has submitted regorafenib, an oral multi-kinase inhibitor for metastatic colorectal cancer, for approval on both sides of the Atlantic.
The filings are based on the Phase III CORRECT trial which showed that regorafenib plus best supportive care significantly improved both overall and progression-free survival, compared to placebo.