For Immediate Release

Mitsubishi Tanabe Pharma Corporation
DAIICHI SANKYO COMPANY, LIMITED

Approval Acquired for Additional Indication for the Selective Antithrombin Agents Novastan® HI Injection 10 mg/2mL and Slonnon® HI Injection 10 mg/2mL For the Inhibition of Thrombosis in Heparin-Induced Thrombocytopenia (HIT) Type II

Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka, President: Natsuki Hayama) and DAIICHI SANKYO COMPANY, LIMITED (Head Office: Tokyo, President & CEO: Takashi Shoda) announced that they obtained approval on July 16 for an additional indication for "the inhibition of thrombosis in heparin-induced thrombocytopenia (HIT) type II" for the selective antithrombin agents "Novastan^® HI injection 10 mg/2mL (manufacture and sale: Mitsubishi Tanabe Pharma Corporation)" and "Slonnon^® HI injection 10 mg/2mL (manufacture and sale: DAIICHI SANKYO COMPANY, LIMITED)" (generic name for both drugs: argatroban hydrate).

 

Heparin-induced thrombocytopenia (HIT) type II is a serious disorder that can lead to fatal thromboembolic disease, but no therapeutic agents have been available for this disorder in Japan until now. Overseas, by contrast, argatroban hydrate has been approved in 10 countries, including the U.S. in 2000.

 

Investigator-initiated trials aimed at the approval of this additional indication were implemented in Japan, because of the strong need for this product for HIT type II patients. As a result the effect of this drug on HIT type II patients was recognized, both companies applied for the approval of this additional indication in September 2007.

 

Both companies will be able to provide the therapeutic agent to HIT type II patients in Japan due to the approval for this additional indication and believe that they can contribute further to needs in clinical practice.

 

Contacts:
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Tel：+81-6-6205-5211

DAIICHI SANKYO COMPANY, LIMITED
Corporate Communications Department
Tel：+81-3-6225-1126