Heart drug wins FDA approval
Dubai, July 21, 2011
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved ticagrelor (Brilinta), a new heart disease medication, to reduce the risk of cardiovascular death and heart attacks in patients with acute coronary syndromes (ACS).
ACS describes any condition brought on by sudden, reduced blood flow to the heart, bringing on chest pain and tightness – often leading to heart attack or stroke. In the UAE acute myocardial infarction, one of the forms of ACS, accounts for 28 per cent of mortality from cardiovascular disease, which is the number one killer.
Ticagrelor is a therapy for patients with ACS. In the US ticagrelor has been indicated to reduce the rate of thrombotic cardiovascular events in patients with ACS (unstable angina non-ST-elevation myocardial infarction, or ST-elevation myocardial infarction).
Ticagrelor has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of ticagrelor. Avoid maintenance doses of aspirin above 100 mg daily.
According to recent clinical trials, ticagrelor is the first medication of its kind to be more effective than clopidogrel, today’s standard of care treatment, in reducing the combined rate of cardiovascular deaths, myocardial infarction, or stroke in patients with ACS.
Additionally, new health economics data presented earlier this year showed that ticagrelor is also more cost-effective based on measure of quality of life than clopidogrel for ACS patients.
Ticagrelor is currently under regulatory review by the UAE Ministry of Health and, pending a positive outcome, could be available to ACS patients in the UAE as early as this year.
“The approval of BRILINTA in the US indicates the FDA’s conviction that ticagrelor is a safe, effective option for patients with ACS. This is an encouraging sign that there can be life after heart attack for ACS patients and our community in the UAE,” said Dr Abdulla Shehab, vice president Emirates Cardiac Society and Associate Professor of Cardiovascular of Medicine, UAE University, Al Ain.
“According to the Gulf Registry of Acute Coronary Events, the average age of ACS patients across the Middle East is 56, which is about a decade younger than patients in the West. As our population ages the incidence of ACS-related health events, such as heart attack, will probably increase. This burden will likely be compounded by risk factors like the high prevalence of smoking and diabetes.”
“The approval of ticagrelor in the US is an important milestone in AstraZeneca’s ongoing commitment to advancing the treatment of cardiovascular disease. We welcome the positive decision and look forward to its potential availability to doctors in our country for use in reducing ACS patients’ risk of heart attack and cardiovascular death,” said Wael Fahmy, Medical and Regulatory director, AstraZeneca Gulf. - TradeArabia News Service
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