Blood clot drug flops

French drug maker Sanofi failed to score brownie points from the Food and Drug Administration’s oncologic drug advisory committee. In a 14 to 1 vote, the committee agreed that there was insufficient proof that blood clot drug semuloparin’s benefits outweigh its risks.

Sanofi sought approval of its heparin – or anticoagulant — injection to treat cancer patients with deep vein thrombosis, a condition in which blood clots form in the body’s deep veins, like those in the thighs. These blood clots can travel to the lungs, disrupt blood flow, and cause a pulmonary embolism, or blockage of the pulmonary artery that leads to the lungs.

Cancer patients undergoing chemotherapy face a 6-and-a-half times higher risk of getting blood clots than those without cancer, and no other medicines are currently approved specifically to prevent clots in chemotherapy patients, Sanofi has said.

In the company’s SAVE-ONCO clinical trial of 3,212 patients, 1.2 percent of those patients taking semuloparin suffered venous thromboembolism, a combination of deep vein thrombosis and pulmonary embolism, or died, compared to 3.4 percent of patients not taking the drug.

These results initially placed the drug in good standing, since it met its goal; however, the FDA noted that a large number of patients suffered bleeding events while taking semuloparin, and one patient died from internal bleeding of the brain. The 3-and-a-half month duration in which patients were evaluated was also of concern. The FDA committee felt that because the risk of venous thromboembolism increases with time, a longer span study could’ve provided more solid results.

Though the FDA is not required to follow the recommendations of its advisory committee, Fox Business stated that it usually does.