Schering-Plough's antiplatelet agent SCH 530348 gets fast track designation from FDA

By Angela McDaniels

Seattle, April 19 - Schering-Plough Corp. said the Food and Drug Administration has granted fast track designation to its investigational oral antiplatelet agent SCH 530348, currently in phase 2 clinical development for prevention of arterial thrombosis in patients with vascular disease such as acute coronary syndrome, prior myocardial infarction, prior stroke or existing peripheral arterial disease.

Platelets activated at the site of an injured blood vessel wall release substances that cause the formation of blood clots. Drugs that block platelet activation by mechanisms such as the thromboxane or ADP mediated pathways have shown reduction in such clinical events, but events continue to occur despite these therapies. Schering-Plough said there is, therefore, a need for new agents that specifically modify the actions of thrombin, the most potent activator of platelets.

SCH 530348 binds selectively to the thrombin receptor on platelets (PAR-1) and is a member of a potentially new class of drugs called thrombin receptor antagonists. The company said it may have the potential to provide clinical benefit through inhibition of this thrombin-mediated platelet activation without increased bleeding, a tendency associated with drugs that block thromboxane or ADP pathways.

Schering-Plough is a health care company based in Kenilworth, N.J., that develops prescription, consumer and animal health products.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.