First Launch Of HMR's Lepirudin Set For May

Hoechst Marion Roussel has been granted approval by the EuropeanMedicines Evaluation Agency for Refludan (lepirudin), a direct thrombin inhibitor. The approved indication for the drug is the treatment of adult patients with heparin-associated thrombocytopenia (HAT) type II and thromboembolic disease requiring parenteral antithrombotic therapy.

Heparin is widely used for anticoagulation, but treatment with the drug can lead to a rare but severe complication, HAT type II. This life-threatening condition occurs in approximately 1% of patients treated with heparin (0.3% to 5% of patients on it for longer than five days). Once the complication arises, it carries with it a mortality of 20%-30% and an amputation rate of 10%-20%, according to recent literature reviews. Lepirudin is the first drug to be specifically approved for the treatment of this condition, according to HMR.

Lepirudin is also the first hirudin-related selective thrombin inhibitor to reach the market. Hirudin has itself been in testing for some time by Novartis (formerly by Ciba), but disappointing results in two angina trials, GUSTO II and TIMI 9b, forced a rethink on the compound last year. It is still being developed for another indication, deep vein thrombosis (Marketletter April 18, 1996), and registration dossiers have been filed.