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Sanofi Blood-Clot Medicine Needs More Study, FDA Staff Says

Sanofi’s drug to prevent blood clots in chemotherapy patients doesn’t have enough data to support approval for that use, U.S. regulators said today.

The data Sanofi submitted on its semuloparin blood thinner “do not provide meaningful support for the approval” as a treatment for venous thromboembolism among high-risk patients receiving chemotherapy for certain cancers, Food and Drug Administration staff said today in a report ahead of June 20 advisory panel meeting on the medicine.

Semuloparin might bring in annual peak sales of 550 million euros ($693 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 company’s own 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 56.07 euros at 2:55 p.m. Paris time.

Awaiting Decision

Sanofi also is awaiting FDA’s decision today on whether to approve its multiple sclerosis drug Aubagio. The FDA hasn’t approved a new drug from Sanofi since it cleared Jevtana on June 17, 2010, for prostate cancer patients whose disease has spread.

Sanofi, based in Paris, applied for 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.

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