Vorapaxar re-launched in U.S. market

Aralez Pharmaceuticals announced its U.S. commercial launch of vorapaxar, an PAR-1 inhibiting antiplatelet therapy, for the reduction of thrombotic CV events.

Vorapaxar (Zontivity, Aralez) is indicated for use in people with a history of MI or in those with peripheral artery disease and should be used in combination with daily aspirin and/or clopidogrel, according to a company press release.

Vorapaxar was developed by Merck and received FDA approval in 2014. Aralez acquired U.S. and Canadian commercial rights to the drug in September 2016. Under terms of that agreement, Merck continued to distribute vorapaxar pending transfer of responsibility to Aralez.

In April, Aralez conducted a phased launch with focused positioning on the targeted population of those with persistent vascular risk and with PAD, diabetes and/or smoking, according to the release.

"We believe Zontivity is a differentiated product that represents a significant opportunity for Aralez as a cornerstone of our [CV] franchise,” Adrian Adams, CEO of Aralez, said in the release. “We are pleased the initial phased launch team has demonstrated immediate results with an inflection in new prescriptions resulting in a doubling of growth with target physicians in only 5 weeks post launch, and are excited about the national roll-out.”

The clinical benefit of vorapaxar was shown in the TRA 2°P TIMI 50 trial, in which participants with a history of MI or PAD with no history of stoke or transient ischemic attack had a 17% relative risk reduction over 3 years for the composite outcome of CV death, MI, stroke and urgent coronary revascularization.