Sanofi failed to win the backing of advisers to U.S. regulators for its drug to prevent blood clots in chemotherapy patients.
Sanofi’s semuloparin doesn’t provide enough of a benefit to outweigh its risks, a Food and Drug Administration panel voted 14-1 today at a meeting in Silver Spring, Maryland. The advisers supported a June 18 FDA staff report that the Paris-based company’s data didn’t “provide meaningful support for the approval” as a treatment for venous thromboembolism among high-risk patients receiving chemotherapy for certain cancers.
Semuloparin might bring in annual peak sales of 550 million euros ($698 million) by 2018 if approved, said Eric Le Berrigaud, an analyst with Bryan Garnier & Co. in Paris, in an interview before the FDA’s report was released. The treatment may compete with the Sanofi’s Lovenox, he said. Lovenox, first approved in 1993, helps prevent blood clots in patients undergoing certain surgeries.
“Doctors may end up preferring cheaper Lovenox copies, now available, rather than a new expensive product,” Le Berrigaud said. “But it’s an important drug for Sanofi, nonetheless. Because it’s one of its new medicines, it’s important for sentiment.”
Sanofi fell less than 1 percent to 57.37 euros at the close of Paris trading.
“Sanofi is disappointed with this outcome as there are currently no anticoagulants approved for this specific indication,” the company said in a statement.
The FDA isn’t required to follow the advisory panel’s recommendation. Sanofi said in the statement it anticipates a decision from the FDA in the second half of this year.
“We still have a lot of unanswered questions,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Drug Products, told the panel at the meeting. “You also have to define in labeling a patient population that is most likely going to benefit from this drug. This has been really the crux of the reason why we brought it to the committee.”
Sanofi also is awaiting FDA’s decision on whether to approve its multiple sclerosis drug Aubagio. The FDA hasn’t cleared a new drug from Sanofi since Jevtana on June 17, 2010, for prostate cancer patients whose disease has spread.
Sanofi asked for approval of semuloparin to treat patients with pancreatic or lung cancers or advanced or spreading solid tumors.
Blood clots in patients on chemotherapy for cancer “has a substantial impact on care,” Giancarlo Agnelli, a professor of internal medicine at the University of Perugia, Italy, wrote in the New England Journal of Medicine in February with other researchers. The complication can lead to hospitalization and chemotherapy interruption.
Symptoms of blood clots or related deaths occurred in 20 of 1,608 patients taking semuloparin in the clinical trial compared with 55 of 1,604 on placebo, according to the journal article. The drug didn’t increase the risk of major bleeding events.