IHS Global Insight Perspective | |
Significance | The Phase III study of AstraZeneca (U.K.)'s Brilinta has demonstrated higher efficacy of the drug than Plavix in the treatment of acute coronary syndrome (ACS) without raising the risk of major bleeding. |
Implications | As the first-in-class cyclo-pentyl-triazolo-pyrimidine (CPTP), Brilinta differs in the way of inhibiting recurrent thrombotic events from other antiplatelets, such as Plavix (clopidogrel bisulphate) and Effient (prasugrel). |
Outlook | The better efficacy results may give Brilinta an edge in the competition against Plavix, while on the other hand, its safety profile is promising to rival Effient, as the latter has been linked to potential events such as excessive bleeding. |
U.K. drug major AstraZeneca yesterday announced the positive results of the Phase III clinical study for its anti-platelet Brilinta (ticagrelor), which was shown as superior to Plavix (clopidogrel)—produced by Sanofi-Aventis (France) and Bristol-Myers Squibb (U.S.)—in the reduction of cardiovascular events in acute coronary syndrome (ACS) patients without increasing the risk of major bleeding.
The late-stage trial, PLATO ("A Study of Platelet Inhibition and Patient Outcomes"), was an international head-to-head trial of Brilinta plus aspirin versus Plavix plus aspirin on 18,264 ACS patients. The results of the PLATO trial, presented yesterday at the European Society of Cardiology congress, demonstrated a statistically significant decrease, with a 16% relative risk reduction in cardiovascular mortality and heart attacks, with no difference in stroke in patients treated with Brilinta as compared to those treated with Plavix.
As the first reversibly binding oral adenosine diphosphate (ADP) receptor antagonist, Brilinta limits recurrent thrombotic events by selectively blocking a key target receptor for ADP, P2Y12. The drug is also different from thienopyridines like Plavix and Effient (prasugrel)—by Eli Lilly (U.S.) and Daiichi Sankyo (Japan)—as the first-in-class cyclo-pentyl-triazolo-pyrimidines (CPTPs). AstraZeneca is expecting to file the new drug application (NDA) for Brilinta in the fourth quarter of this year.
Outlook and Implications
AstraZeneca had already revealed the superiority of Brilinta to Plavix in the treatment of ACS earlier this year based on positive Phase III results, although the detailed, full results were not available till now (see United Kingdom: 11 May 2009: AstraZeneca Touts Brilinta as Superior to Plavix in Acute Coronary Syndrome Patients). The announcement of the full results is now giving a more detailed insight into the clinical performance of Brilinta, which is set to compete against the major antiplatelets on the market, including Plavix and the newly approved Effient.
Brilinta's clinically proven better efficacy than Plavix in ACS treatment will give the drug an edge in terms of competition for market share in the lucrative ACS treatment market. In 2008, the multi-blockbuster Plavix alone racked up global sales revenue of over US$9 billion. If Brilinta can gain regulatory approval in the primary markets, such as the United States and Europe, Plavix is likely to face a potentially significant threat to its dominance of ACS treatment.
In terms of Effient, Brilinta is to have a strong rival in the European and U.S. markets, where regulatory approvals were recently granted to Effient (see United States: 13 July 2009: Daiichi Sankyo, Eli Lilly Clinch FDA Nod for Effient, Lilly's Alimta Approved as NSCLC Monotherapy in EU). However, Effient has been dogged by concerns over potential adverse events, including excessive bleeding, during the process of its regulatory review. Brilinta may therefore have the upper hand with its safety profile as no increase in major bleeding was observed in the PLATO study.