Sanofi's attempt to gain its first new drug approval in two years experienced another setback today as a committee of external experts decisively voted against an OK for semuloparin, a treatment designed to prevent blood clots among patients receiving chemotherapy. The advisers concluded that Sanofi ($SNY) didn't proffer a clear picture of who would benefit from the treatment, particularly worrying given their risk of bleeding.
The 14 to 1 landslide likely buried any remaining chance of a near-term approval for the treatment. FDA staffers have already concluded that Sanofi's R&D team failed to provide "meaningful support for the approval." From the staff perspective, the data were corrupted by the fact that few patients in the pivotal study actually experienced clotting issues, with most of the patients dying from other causes, clouding the efficacy.
"Cancer patients have a lot to deal with just in treating their cancer with chemotherapy," noted panel member Dr. Mikkael Sekeres, from the Cleveland Clinic Taussig Cancer Institute, according to the Reuters report on the vote. "When we add ... medicines to prevent complications, we have to be particularly careful in not adding harm."
In a prepared release, Sanofi noted that there are no existing treatments to prevent clotting in at-risk chemo patients. But it's unlikely that the agency will officially reverse both the staff and its experts. Sanofi's best chance for a near-term approval lies with two MS drugs, Aubagio and Lemtrada, which are in the hands of its Genzyme unit.