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Европейцы одобрили ривораксобан при ОКС, FDA нет. Кто прав?

Rivaroxaban gets ACS indication recommendation from European regulators

London, UK - In a surprise move, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a "positive opinion" regarding extending the indication for rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals) to include prevention of atherothrombotic events in adult patients with acute coronary syndromes [1].

The move by the European review agency comes within weeks of news that the US Food and Drug Administration (FDA) opted not to approve the drug for this indication at this time, instead issuing a complete response letter to the sponsor, an indication that the regulator was seeing additional information, as reported by heartwire.

In a summary of opinion released today, the CHMP recommended a new indication, for a new 2.5-mg strength for the drug.

"Xarelto, coadministered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers."

The CHMP recommendations today now await final approval by the European Commission. A 2.5-mg dose was one of two strengths tested in the pivotal ATLAS ACS 2 TIMI 51 trial. In the trial, the 2.5-mg dose showed a reduction in overall and cardiovascular mortality vs placebo, despite an increased risk of bleeding and intracranial hemorrhage (ICH). In the higher, 5-mg dose, however, a higher bleeding risk outweighed the benefits.

The drug is already approved in the 10-mg dose for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip- or knee-replacement surgery and in 15-mg and 20-mg doses for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age >75 years, diabetes mellitus, or prior stroke or transient ischemic attack. The 15-mg and 20-mg doses are also already approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

That's not the end of the indications in which the sponsor hopes rivaroxaban can play a role. Earlier in March, Janssen announced the launch of EXPLORER, a global research program encompassing five new studies, two of which will test rivaroxaban in the setting of coronary artery disease or peripheral artery disease and another in patients with chronic heart failure. When all's said and done with these trials and those that led to the currently approved indications, more than 100 000 patients will have participated in a company-sponsored rivaroxaban trial, a press release noted.

Источник http://www.theheart.org/article/1521155 ... newsletter

Ссылки по теме:

ATLAS ACS 2: Low-dose rivaroxaban looks good in ACS http://www.theheart.org/article/1309137.do

ATLAS ACS 2 TIMI 51: 2.5-mg rivaroxaban cuts cardiac events in STEMI http://www.theheart.org/article/1441351.do

Rivaroxaban STEMI study hits print as FDA delivers setback: ATLAS ACS 2-TIMI 51 http://www.theheart.org/article/1514185 ... newsletter

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Я вас всех люблю, но порядок должен быть!

Хотелось бы узнать от EBM про ривароксабан и ФП.
Из Новосибриска приезжают пациенты с рекомендациями на ксарелто. Это уже законно? Или только рекомендательно.

При ФП законно. Препарат зарегистрирован в России. http://www.vidal.ru/poisk_preparatov/xarelto.htm

Доказательная база:
На русском - http://www.mif-ua.com/archive/article/14826
на буржуйском http://www.nejm.org/doi/full/10.1056/NEJMoa1009638

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Я вас всех люблю, но порядок должен быть!

В гайдах про ОКС как-то смутно про эту ксарелту.

Ещё мало времени после исследования прошло.

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Я вас всех люблю, но порядок должен быть!