Days after winning priority review status for Nexavar in Japan as a liver cancer therapy, Bayer is celebrating the decision by the country’s healthcare regulators to approve the drug for the treatment of advanced renal cell carcinoma.

Nexavar (sorafenib), which was co-developed with the USA’s Onyx Pharmaceuticals, has been given the green light by Japan’s Ministry of Health, Labour and Welfare for kidney cancer, following approvals that have already been secured in the USA and Europe. Some 10,000 people are thought to suffer from the disease in Japan and Bayer is encouraged by the fact that Nexavar is the first approved oral targeted therapy for metastatic RCC.

This means that Nexavar will be able to steal a march in Japan on rival advanced kidney cancer disease drugs, namely Wyeth’s Torisel (temsirolimus) and Pfizer’s Sutent (sunitinib).

Sanofi’s Clexane approved
Staying with Japan, the JMHLW has also approved Sanofi-Aventis’ blockbuster anticoagulant Clexane (enoxaparin), better known as Lovenox, for the prevention of venous thromboembolism in patients undergoing orthopaedic surgery of the lower limbs such as total hip replacement, total knee replacement and hip fracture surgery.