Health Canada approves Brilinta

RNS Number : 6315H

AstraZeneca PLC

01 June 2011

 



HEALTH CANADA APPROVES BRILINTA

(Ticagrelor TABLETS)

AstraZeneca today announced that Health Canada has approved BRILINTA (ticagrelor tablets) for the secondary prevention of atherothrombotic events in patients with Acute Coronary Syndromes (ACS).

It is estimated that approximately 122,000 Canadians have an ACS event every year. Data suggests that up to 15 percent of patients with ACS die within one year of their cardiovascular event.

With the approval in Canada, BRILINTA has now been approved in 33 countries, including in the European Union under the trade name BRILIQUE and in Brazil, Malaysia, and Macau under the trade name BRILINTA. The product is currently under regulatory review in 42 countries, including the United States, Russia, India, and China.

The approval of BRILINTA in Canada is supported by data from the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) study which established the superiority of ticagrelor with aspirin over clopidogrel with aspirin for the prevention of another cardiovascular event in hospitalised ACS patients.  

Like all medicines, BRILINTA can cause side effects, although not every patient will experience them. The most common adverse events reported by patients on BRILINTA include an increase in bleeding (such as nosebleeds), shortness of breath and headache.

NOTES TO EDITORS:

The decision by Health Canada to approve BRILINTA is an independent regulatory authorisation of the product and has no bearing on the ongoing reviews of BRILINTA in other markets.

About BRILINTA (ticagrelor tablets)

BRILINTA is an oral antiplatelet treatment for acute coronary syndrome (ACS) in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA 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 is the first reversibly-binding oral adenosine diphosphate (ADP) receptor antagonist.

In Canada, BRILINTA, co-administered with aspirin, is indicated for the secondary prevention of atherothrombotic events in a broad ACS population. Specifically, BRILINTA is indicated for use in patients who are diagnosed with unstable angina (UA) or who experience a heart attack [either non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)]. BRILINTA is indicated for use in these patients whether they are to be managed with medical therapy alone or via an invasive procedure [percutaneous coronary intervention (PCI) and/or coronary artery by-pass graft (CABG)]. BRILINTA is recommended to be co-administered with a low maintenance dose of aspirin (75-150 mg).

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.

About the PLATO study

PLATO was a large, international (18,624 patients in 43 countries), head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel.

The study demonstrated that treatment with BRILINTA with aspirin led to a greater reduction in the primary endpoint [a composite of death from vascular causes, heart attack (myocardial infarction or MI), or stroke] compared to patients who received clopidogrel with aspirin (9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92; p<0.001). The study also demonstrated that treatment with BRILINTA with aspirin for 12 months was associated with a 21 percent RRR in cardiovascular death (3.8% vs. 4.8%; p<0.002) compared to clopidogrel with aspirin at 12 months.

As with all oral antiplatelet medications, the use of BRILINTA can increase the risk of bleeding. In PLATO, there was no difference in overall major bleeding (11.6% vs. 11.2%, p=0.43) or in fatal/life-threatening bleeding episodes (5.8% vs. 5.8%, p = 0.70) between patients treated with BRILINTA with aspirin compared to those treated with clopidogrel with aspirin. However, non-CABG major and non-procedural major bleeding was more common with BRILINTA vs. clopidogrel (4.5% vs. 3.8%, p=0.03 and 3.1% vs. 2.3%, p=0.06, respectively).

401 ACS patients from Canada participated in the PLATO study.

About Acute Coronary Syndromes (ACS)

ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (severe chest pain at rest that threatens a heart attack) to heart attack.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Media Enquiries Global

Donna Huang    [phone]        mob: [phone] (US)

Laurie Casaday [phone]       mob: [phone] (US)

Media Enquiries UK

Esra Erkal-Paler           [phone] (24 hours)
Abigail Baron                 [phone] (24 hours)

Isabelle Jouin                [phone] (24 hours)

Investor Enquiries UK

Jonathan Hunt              [phone]      mob: [phone]
Karl Hård                      [phone]      mob: [phone]
Nicklas Westerholm    [phone]         mob: [phone]

Investor Enquiries US

Ed Seage                      [phone]          mob: [phone]
Jorgen Winroth             [phone]          mob: [phone]

1^st June 2011

                                                               Ends

 

END

 

 

MSCGUGDLSGGBGBB