AstraZeneca’s drug Brilinta has lagged its rivals in the antiplatelet market, but the company is hoping a new reversal agent designed to make its use safer will boost the product.
The company’s biotech subsidiary Medimmune has developed an antibody – called MEDI2452 – that can counteract the anticlotting effects of Brilinta (ticagrelor), for example if a patient receiving the drug suffers a major bleeding episode or has to undergo emergency surgery.
While MEDI2542 is still in preclinical testing, AZ intends to fast-track it through development. If it is approved it would make Brilinta the first oral antiplatelet drug on the market with an antidote.
Brilinta was launched in 2011 to great fanfare as a treatment for patients with acute coronary syndrome (ACS) that could step into the premium antiplatelet space vacated by Sanofi’s mega-blockbuster Plavix (clopidogrel), which saw its sales pummelled by generic competition after key patents expired in 2012.
Almost immediately however, AZ’s product was beset by concerns about the reliability of data in the PLATO trial underpinning Brilinta’s approval which eventually escalated into a full-blown inquiry by the US Department of Justice into the conduct of the study.
AZ was happy to let Brilinta idle along while the DoJ enquiry played out, but since the close of the probe in the summer the company has put its foot firmly back on the accelerator.
Now it has started focusing on the benefits of its drug versus Plavix and its generics, including a 21% reduction in cardiovascular deaths in the PLATO trial as well as data suggesting it is much more effective than its rival in a subgroup of ACS patients with a high level of troponin in their blood.
Brilinta (sold as Brilique in Europe) also has competition in the form of Eli Lilly and Daiichi Sankyo’s Effient (prasugrel), although the latter has been held back by a higher risk of bleeding despite also outperforming Plavix in efficacy trials.
AZ’s drug is now considered the preferred oral antiplatelet drug by the American Heart Association (AHA) and American College of Cardiology (ACC), and having an effective reversal agent could encourage greater use by cardiologists.
Marc Ditmarsch, global development lead for Brilinta at AZ, said: “Doctors need to have the option to swiftly reverse the effects of oral antiplatelet agents. If the circumstances demand it, we believe MEDI2452 has the potential to help address this need.”
In addition to the reversal agent programme, AZ also has five additional registration studies ongoing in patients with atherothrombotic disease, including the PEGASUS study looking at long-term prevention, SOCRATES in ischaemic stroke, THEMIS in atherosclerosis and EUCLID for peripheral artery disease (PAD).
Sales of Brilinta are already showing signs of increased momentum, rising 78% to $343m and – while a far-cry from Plavix’ peak sales of around $9bn a year – sets the product on the road to meeting AZ’s sales target of $3.5bn-a-year for the product by 2023.