FDA actions

FDA actions

The highly anticipated oral factor Xa inhibitor rivaroxaban has been approved by the FDA to reduce the risk of deep venous thrombosis, blood clots, and pulmonary embolism in patients undergoing knee or hip replacement. The once-a-day medication should be taken for 12 days by patients undergoing knee replacement and 35 days for patients undergoing hip replacement. The approval was based on three studies (RECORD 1, 2, and 3) which showed that rivaroxaban is superior to subcutaneous enoxaparin in this role. Bleeding, the primary side effect of the drug, was no more common with rivaroxaban than enoxaparin. Rivaroxaban also has been looked at in phase III trials for stroke prevention in patients with nonvalvular atrial fibrillation, and treatment and secondary prevention of venous thromboembolism, although the FDA has yet to act on approval for these indications. Rivaroxaban was developed by Bayer and is marketed by Janssen Pharmaceuticals as Xarelto.

The FDA has approved ticagrelor, a new antiplatelet drug for patients with acute coronary syndrome, including unstable angina and myocardial infarction (MI). The approval was based on studies that coupled ticagrelor with low-dose aspirin. The approval recommends use with aspirin although it carries a warning that aspirin doses above 100 mg per day may decrease the effectiveness of the drug. Ticagrelor requires twice a day dosing in contrast to the other drugs in this class, clopidogrel and prasugrel, which can be dosed once daily. The approval was based on the PLATO trial, a head-to-head study with clopidogrel which showed that in combination with aspirin, ticagrelor resulted in the lower composite endpoint of cardiovascular death, stroke, or MI (9.8% vs 11.7% with clopidogrel, P < 0.001).

The FDA has approved six manufacturers for the 2011-2012 flu vaccine. The strains included this year are A/California7/09 (H1N10), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 the exact same components as last year's vaccine. One of the manufacturers, Sanofi Pasteur, has received permission to market Fluzone Intradermal, the first flu vaccine administered via a novel intradermal microinjection that is touted as being more comfortable than intramuscular injections. The new intradermal system in approved for adults ages 18-64 years.