WASHINGTON, June 18 (Reuters) - U.S. drug reviewers questioned the value of preventing blood clots with Sanofi SA’s semuloparin injection for cancer patients receiving chemotherapy.
The Food and Drug Administration staff said only a small number of people in the clinical trials for semuloparin actually had issues with clotting, and most people died from other problems.
“These findings call into question the clinical value of semuloparin in the proposed clinical setting,” the FDA reviewers said in documents posted online on Monday.
The FDA staff review comes ahead of an advisory panel, which will vote on whether to recommend semuloparin on Wednesday. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.