Sanofi has withdrawn its application to market its investigational anticoagulant Mulsevo in the European Union and elsewhere, a couple of weeks after advisors to the US Food and Drug Administration firmly recommended against approval.
News of the withdrawal was revealed by the European Medicines Agency which was notified by the French drugmaker to pull its request for a centralised marketing authorisation for Mulsevo (semuloparin) for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumours.
The application was submitted to the EMA in September last year and was under review by the agency’s Committee for Medicinal Products for Human Use. In its withdrawal letter, Sanofi stated it has decided to withdraw all applications globally "following comments by regulatory agencies".
Last month, the FDA's Oncologic Drugs Advisory Committee voted 14 to 1 (with one abstention) not to recommend approval of semuloparin for the prevention of VTE in patients receiving chemotherapy for metastatic lung or pancreatic cancer. The panel also rejected the injectable drug for use in patients with advanced solid tumours with a VTE risk score greater than or equal to three.
At ttime of writing, Sanofi had yet to make any official comment but company spokesman Jean-Marc Podvin told Bloomberg that "we are evaluating the next steps for semuloparin, to determine the appropriate path forward for the compound".