AstraZeneca Pharma India Limited (AZPIL) has now introduced a new patented antiplatelet drug Brilinta (Ticagrelor) in the country.
Brilinta is an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients. The drug is competitively priced to enable ACS patients benefit from having access to this medicine. It 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. Te approval was based on the submission of data from the landmark 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 and effective treatment to help reduce the rate of heart attack and cardiovascular deaths in these patients. Such exciting medical breakthroughs don’t happen very often.”
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.
The drug Brilinta is in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). It works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce a patient’s risk of another cardiovascular event called atherothrombotic events such as a heart attack or cardiovascular death.
Brilinta will be available in 90 mg tablets to be administered with a single 180 mg oral loading dose of 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. The drug is a is a registered trademark of AstraZeneca in India and other countries.
Like all medicines, Brilinta may cause side effects, although not every patient will experience them. The most common side effects reported with Brilinta were bleeding and shortness of breath. Bleeding occurs commonly with any potent platelet inhibitor. With Brilinta, severe bleeding is uncommon, while less severe bleeds such as bruising and nosebleeds are common. Shortness of breath often resolved during the treatment and led uncommonly to patients stopping Brilinta in the PLATO study. Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhoea, rash, itching, and upset stomach.
ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina to heart attack.
AZPIL is engaged in manufacturing and marketing of branded generics. In India, the company employs more than 1900 employees of which approximately 1450 are part of the commercial organization, 250 involved in manufacturing, 200 are in R&D including more than 90 scientists of international repute focused on TB research for discovering new and novel therapeutic agents. The rest are employed in the clinical trials and global external sourcing.