Argatroban Gets Stroke Indication In Japan

Mitsubishi Chemical's selective thrombin inhibitor Novastan (argatroban) has been approved for the treatment of acute ischemic stroke in Japan. The drug has been marketed for other indications in Japan since 1990.

The new approval was granted on the back of Phase III results, which showed that treatment with argatroban led to a statistically-significant neurological improvement 28 days after presentation, compared to placebo. 59.2% of the argatroban-treated patients improved, compared to 23.7% of the placebo group. Furthermore, most of the benefits were accrued in the first 48 hours after treatment (67% for argatroban versus 23% for placebo).

Interestingly, argatroban caused surprisingly few major bleeding events; the actual number was less in the treated group than in the placebo group. This data was presented recently at the 30th Annual Penner Blood Coagulation Conference in Hawaii, USA, by Shotai Kobayashi of Japan's Shimane Medical University.