The Wall Street Journal (1/16, Subscription Publication, 5.91M) reports Johnson & Johnson and Bayer AG did not receive the backing of an FDA advisory panel to expand the use of their blood-thinner Xarelto (rivaroxaban) as a potential therapy for patients with a certain heart problem The paper says the decision follows a review of the results of a Phase 3 trial.
Bloomberg News (1/16, Edney, 1.91M) reports the rejection by the panel raises “another challenge in the companies’ repeated effort to sell the drug to a bigger group of heart patients.” Xarelto “shouldn’t be approved to help prevent heart attacks and strokes 90 days after patients experience serious chest pain or cardiac illness, a condition known as acute coronary syndrome,” according to the panel, which voted 10-0 today with one abstention. Bloomberg says this the company’s “third attempt to gain FDA clearance for such patients.”
The AP (1/17) provides details of the panel’s argument in rejecting the expanded use of the medication, “saying too much information is missing from company studies to accurately gauge Xarelto’s benefit.”
CardioSource (1/17, 2K) points out that the medication “is FDA-approved to prevent stroke in non-valvular atrial fibrillation, treat deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and reduce the risk of recurrence of DVT and PE following initial treatment, and prevent DVT after knee or hip replacement surgery.” Also covering the story are Reuters (1/17), Forbes (1/16, 6.03M), MedPage Today (1/17, 122K), and Medscape (1/17, 164K).
Posted by: Steven Almany M.D.