The experimental drug Semuloparin which acts to prevent blood clots and was considered as an alternative to standard heparins, has been withdrawn by it’s European based manufacturer Sanofi. They have announced today that they will no longer be seeking marketing approval for the experimental medication.
Semuloparin is classified as an ultra-LMWH because of its low molecular mass of 2000 – 3000 Daltons on average. (Enoxaparin has 4500 Daltons.) These low mass heparins have lower anti-thrombin activity than classical LMWHs and act mainly on factor Xa, therefore reducing the risk of bleeding, that has sometimes been a problem with traditional herparins.
Sanofi advised the European Medicines Agency (EMA), on Monday in a letter, that it was withdrawing the application it filed last year. It is also withdrawing applications elsewhere in the world. The meeting to decide on the anti-coagulant was due to be held next week.
The media is reporting that Sanofi could not be reached for comment and the company gave only a short statement saying that indications from government agencies were negative and it elected to pull the application rather than proceed.
In the US, Sanofi’s application to use Semuloparin to prevent venous thromboembolism (VTE) in cancer patients taking chemo was denied by the FDA who voted 14-1 against the application. Panel members commented that VTE events and deaths were no better than placebo.
It’s a blow to the company’s bottom line, with sales of the drug projected to hit some $300M by 2017. The company is awaiting approval of a multiple sclerosis drug Aubagio by US regulators, but Sanofi lacks much in the way of new products in it’s pipeline and hasn’t had a solid approval since Jetvana was approved in 2010 for prostate cancer that had started to spread.
In June this year, results form the SAVE-ONCO trial appeared to show promise for chemotherapy patients – showing considerable reductions in thromboembolic events, so the announcement is disappointing for everyone from healthcare professionals to patients and company shareholders.
Written by Rupert Shepherd