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