U.S. advisers shoot down Sanofi anti-clotting drug
Last Updated: 2012-06-20 14:01:37 -0400 (Reuters Health)
SILVER SPRING, Md., June 20 (Reuters) - French drugmaker Sanofi failed to win a U.S. panel's support on Wednesday for an injection meant to prevent blood clots in certain cancer patients, making it unlikely the drug would get approval in the United States.
A panel of outside advisers to the Food and Drug Administration voted 14 to 1, with one abstention, to recommend rejection of the semuloparin injection for cancer patients getting chemotherapy who are particularly at risk for blood clots.
The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.
Most panel members said the company had not done a good job of defining exactly which patients would most benefit from the drug, especially as those taking the medicine were also at higher risk of bleeding.
"Cancer patients have a lot to deal with just in treating their cancer with chemotherapy," said panel member Dr. Mikkael Sekeres, from the Cleveland Clinic Taussig Cancer Institute.
"When we add ... medicines to prevent complications, we have to be particularly careful in not adding harm."
In documents posted before the panel meeting, FDA staff reviewers questioned the clinical value of semuloparin, since only a small number of people who took the drug in clinical trials actually had issues with clotting, and most people died from other problems.
Sanofi has said cancer patients getting chemotherapy have a 6.5 times higher risk of getting blood clots than patients without cancer, and no other medicines are currently approved specifically to prevent the clots in patients on chemotherapy.
But during the clinical trial, only 3.4 percent of people who took a placebo had a blood clot. At the same time, about 5 percent of patients died from other causes, raising doubts about the importance of preventing blood clots in cancer patients.
Semuloparin was also tied to a higher risk of bleeding compared with a placebo, with about one-fifth of patients having some bleeding issues while taking the drug, including bleeding into a critical area or organ.