Drugs

Ticagrelor Trial Misses Primary Endpoint

AstraZeneca says that the SOCRATES trial that assessed the efficacy of Brilinta/Brilique (ticagrelor) compared with aspirin in patients with acute ischemic stroke or transient ischemic attack missed its primary endpoint of time to first occurrence of any event from the composite of stroke, heart attack, and death. “Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population, but the trend did not reach statistical significance,” the company says.

Brilinta/Brilique is described as a direct-acting P2Y₁₂receptor antagonist that works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular events. Its 90mg dose is indicated to reduce the rate of thrombotic cardiovascular events in patients with unstable angina, non-ST-elevation myocardial infarction, or ST-elevation myocardial infarction. A 60mg dose is indicated for treating patients who have suffered a heart attack at least one year prior and are at high risk for developing a further atherothrombotic event.

The drug, AstraZeneca says, has been shown to reduce the rate of a combined endpoint of cardiovascular death, heart attack, or stroke compared to clopidogrel. It says the difference between treatments was driven by cardiovascular death and heart attack, with no difference in stroke. In patients treated with percutaneous coronary intervention, it reportedly also reduces the rate of stent thrombosis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome