Outlook Not Good on FDA Approval of Semuloparin Blood Thinner

Posted on June 18, 2012

The Food and Drug Administration needs more information before they can approve a new drug for the prevention of blood clots in individuals who are in the process of undergoing chemotherapy.

The drug being considered is a blood thinner known as semuloparin.  Produced by the Paris-based Sanofi, it was hoped by the company that the drug could be approved as a way to prevent venous thromboembolism in persons receiving chemotherapy for the treatment of pancreatic cancer, lung cancer, and various other tumors that could be spreading throughout an individual’s body.

In a clinical trial conducted by the company in order to determine the safety and efficacy of the drug, 20 people out of more than 1,600 died or suffered symptoms indicative of a blood clot.  Among those persons who had taken placebos instead of the drug, 55 experienced similar adverse events.  In addition, it was discovered that semuloparin did not contribute to the danger that a major bleeding event was going to occur in a patient.

Despite these statistics, the FDA has come to the conclusion that not enough information was provided that could support an approval of the drug.  As of right now, though, it’s not quite the end of the road for the drug.  An advisory panel will meet on Wednesday to consider whether or not approval is warranted.

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