AstraZeneca's patented heart drug debuts in India

Brilinta is indicated to reduce heart attack and cardiovascular death in patients with Acute Coronary Syndromes

AstraZeneca Pharma India Limited (AZPIL) has announced the launch of a new patented antiplatelet drug Brilinta (Ticagrelor) in India. Brilinta is an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients. Brilinta works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient's risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death.

The Drug Controller General of India (DCGI), based on the New Drug Advisory Committee's (NDAC) recommendations granted its approval in May 2012 for marketing Brilinta (Ticagrelor) tablets in India. The DCGI approval is based upon the submission of data from the PLATO (Platelet Inhibition and Patient Outcomes) trial, comparing treatment with Brilinta to Clopidogrel - the current standard of care, available in the market for over a decade.

 

Dr Paurus Irani, Vice President Medical & Regulatory Affairs of AstraZeneca Pharma India Limited said, "With over 40 lakh people affected by ACS in India each year, Brilinta gives cardiologists a new treatment to help reduce the rate of heart attack and cardiovascular deaths in these patients." To date, Brilinta has been approved in 83 countries and launched in 63 countries (including India now) under the trade name Brilinta and in the European Union under the trade name Brilique.

Brilinta will be available in 90 mg tablets to be administered with a single 180 mg oral loading dose (two 90 mg tablets) followed by a twice daily, 90 mg maintenance dose. Following an initial loading dose of aspirin, Brilinta should be used with aspirin.