Briefing documents question semuloparin efficacy

FDA reviewers said the efficacy of semuloparin from Sanofi (Euronext:SAN; NYSE:SNY) to prevent venous thromboemoblism (VTE) appears to be "small" relative to the overall mortality in cancer patients receiving chemotherapy. The comments came in briefing documents released ahead of Wednesday's meeting of the Oncologic Drugs Advisory Committee to discuss an NDA for the ultra-low molecular weight heparin. Sanofi is seeking approval to prevent VTE in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer, or for locally advanced or metastatic solid tumors at high risk of VTE. There are no low molecular weight heparins or other anticoagulants approved for the proposed indication.

The NDA is based on the Phase III SAVE-ONCO trial, which showed semuloparin met the primary endpoint of improving the composite of any symptomatic deep vein thrombosis, non-fatal pulmonary embolism or VTE-related death compared with placebo (1.2% vs. 3.4%, p<0.0001). However, the documents noted that premature censoring compromised the results, as 32.5% of patients discontinued treatment within the first three months. Reviewers added that other trials of semuloparin in better-understood VTE prophylaxis indications, such as patients undergoing orthopedic and major abdominal surgery, do not provide "meaningful support" for the approval of semuloparin for the proposed indication. In 2010, Sanofi reported that semuloparin missed the primary endpoint of non-inferiority to the pharma's Lovenox enoxaparin in the Phase III SAVE-ABDO trial to prevent VTE in patients undergoing major abdominal surgery. ...