Strike 2 For Once Promising GSK ‘Stinkbomb’ Heart Drug

GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company  announced that another phase 3 trial with the same drug had  failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it…

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FDA Once Again Rejects New Indication For Rivaroxaban

The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…

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Younger Women With Acute Coronary Syndromes Less Likely To Have Classic Chest Pain

Younger women with an acute coronary syndrome are slightly less likely than men to present with the classic symptom of chest pain, according to a new study published in JAMA Internal Medicine. In recent years there has been a growing understanding that women with ACS are less likely to have chest pain and, partly as a result,…

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New Test Could Speed Heart Attack Treatment In The Emergency Department

Only 1 in 10 patients with acute chest pain in the emergency department turn out to have an actual heart attack (myocardial infarction), yet many are not released from the hospital until after 6-12 hours of cardiac monitoring and multiple ECG and troponin tests. The search for a test that can rule out MI early in…

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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to…

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FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)

For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…

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Expert Consensus Document Offers Advice On Troponin Tests

A newly published document provides practical advice on the use of the popular and potent troponin tests. The Expert Consensus Document on Practical Clinical Considerations in the Interpretation of Troponin Elevations was developed by the American College of Cardiology Foundation in collaboration with several other societies to help address the many complex issues raised by the introduction…

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“Dramatic” Increase In Bleeding Accompanies Addition Of Oral Anticoagulant Therapy In ACS

The newer oral anticoagulants may help reduce ischemic events after an acute coronary syndrome (ACS), but only at the cost of a “dramatic” increase in bleeding complications, according to a new meta-analysis published in the Archives of Internal Medicine. Hungarian researchers performed a systematic review and meta-analysis of seven trials in which 31,286 ACS patients were randomized to…

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TRILOGY At ESC: No Advantage For Prasugrel Over Clopidogrel In Medical ACS Patients

The newer antiplatelet agent prasugrel was no better than the old standby clopidogrel for treating patients with acute coronary syndrome (ACS) who are not undergoing revascularization. The results of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial were presented by Matt Roe at the European Society of…

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FDA Rejects ACS Indication for Rivaroxaban (Xarelto)

The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on…

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FDA Advisory Committee Recommends Against ACS Indication For Rivaroxaban

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against adding an indication for acute coronary syndromes (ACS) to the label  of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI…

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Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS

Here’s my live-blogg of the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to consider the supplemental new drug application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. Here is a link to the FDA briefing documents. ========================= 4:48: Meeting adjourned! J&J has just issued a press release…

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