Texas gets approvable letter for Argatroban sNDA

Texas Biotechnology has received an approvable letter from the US Foodand Drug Administration for a supplemental New Drug Application for its direct thrombin inhibitor argatroban, which is marketed by GlaxoSmithKline. The sNDA defines dosing guidelines that further expand the treatable patient population to include patients who have or who are at risk of developing thrombosis associated with heparin-induced thrombocytopenia and who are undergoing percutaneous coronary intervention.

Argatroban, which was launched in the USA, its first market, for the prophylaxis or treatment of thrombosis in patients with HIT last year (Marketletter November 20, 2000), is currently in a Phase II trial to evaluate the safety and efficacy for use as a monotherapy in ischemic stroke patients. It is also expected to enter another Phase II trial later this year in combination with glycoprotein IIb/IIIa inhibitors, such as Eli Lilly's ReoPro (abciximab).