September 27th, 2012
The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly praised when […]
May 31st, 2012
Among patients with atrial fibrillation (AF), women have a higher risk than men of having a stroke, according to a new study published in BMJ. The increased risk was mostly found in women over 65 years of age and in women with multiple risk factors. Leif Friberg and colleagues analyzed data from more than 100,000 Swedish patients with […]
April 30th, 2012
This week, Richard looks at endocarditis and ICDs, more stent wars, stroke prevention in A-Fib, and more.
November 4th, 2011
The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the […]