Semuloparin (Sanofi) may need more data for FDA approval for prophylaxis of VTE

Semuloparin, a low molecular weight heparin from Sanofi ,is filed at the FDA for the prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors. FDA regulators have commented that the application does not have enough data to support its approval for that use. The FDA Advisory Panel meets to review the application on 20 June 2012.Semuloparin is seen as a successor to Lovenox(enoxaparin).