AstraZeneca announced on 6th December 2010 that the European Commission has granted marketing authorisation to BRILIQUE™ (ticagrelor tablets) for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (ACS). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use on 23rd September and is applicable to the 27 Member States and the 3 European Economic Area countries of the European Union.(1)
BRILIQUE (Ticagrelor) is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.
BRILIQUE, a prescription oral antiplatelet treatment, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (unstable angina, NSTEMI, or STEMI), including patients managed medically and those who are managed with percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting (CABG).
The majority of launches will occur in the second half of the year due to pricing and reimbursement negotiations.
The marketing authorisation for BRILIQUE is based on a review of the ticagrelor clinical programme, including results from PLATO (A Study of PLATelet Inhibition and Patient Outcomes), which established the superiority of ticagrelor over clopidogrel, and showed that treating 54 ACS patients with ticagrelor instead of clopidogrel for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular death, with no increase in overall major/fatal bleeding over the course of one year of treatment (11.6% for BRILIQUE vs. 11.2% for clopidogrel, p=0.43).
In the PLATO trial (2) the ticagrelor and clopidogrel groups did not differ significantly with regard to the rates of major bleeding as defined in the trial (11.6% and 11.2%, respectively; P = 0.43). There was also no significant difference in the rates of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) criteria (7.9% with ticagrelor and 7.7% with clopidogrel, P = 0.57) or fatal or life-threatening bleeding (5.8% in both groups, P = 0.70). The absence of a significant difference in major bleeding according to the trial definition was consistent among all subgroups, without significant heterogeneity, except with regard to the body-mass index (P = 0.05 for interaction). The two treatment groups did not differ significantly in the rates of CABG-related major bleeding or bleeding requiring transfusion of red cells. How-ever, in the ticagrelor group, there was a higher rate of non–CABG-related major bleeding according
to the study criteria (4.5% vs. 3.8%, P = 0.03) and the TIMI criteria (2.8% vs. 2.2%, P = 0.03). With ticagrelor as compared with clopidogrel, there were more episodes of intracranial bleeding (26 [0.3%] vs. 14 [0.2%], P = 0.06), including fatal intracranial bleeding (11 [0.1%] vs. 1 [0.01%], P = 0.02). However, there were fewer episodes of other types of fatal bleeding in the ticagrelor group (9 [0.1%], vs. 21 [0.3%] in the clopidogrel group; P = 0.03). Dyspnea was more common in the ticagrelor group than in the clopidogrel group (in 13.8% of patients vs. 7.8%)
Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhea, rash, itching, and upset stomach.
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