FDA Says More Data Needed for Sanofi's (SNY) Semuloparin in Chemo Patients

June 18, 2012 9:04 AM EDT
Sanofi (NYSE: SNY) is indicated for a lower open Monday following reports that the FDA is questioning effectiveness of its proposed blood-clot medication.

According to Bloomberg, the FDA said it doesn't have enough data to support approval for the blood-thinner semuloparin following chemotherapy.

Specifically, Sanofi recently rtevised its NDA to read: "Semuloparin is indicated for gprophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score >= 3."

For the complete FDA note, click here.

Sanofi is about 0.5 percent lower in early trading.

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