The US Food and Drug Administration (FDA) has asked Sun Pharmaceutical Industries to stop trials on one dose of a dermatological drug due to the potential of blood clots, informed a company statement.
The company said, “The agency has placed the IND on partial clinical hold, due to the potential for thrombotic events, and are requiring that subjects currently on the 12 mg BID dose in the OLE studies to discontinue that dose. There have been no thrombotic events reported to date for the 8 mg BID dose and US FDA has not placed the 8 mg BID dose on hold. We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies.”
It added, “No thromboembolic events were observed during Phase-2 or Phase-3 trials, and we remain confident in deuruxolitinib’s potential to treat patients with Alopecia Areata and will work closely with the US FDA to address the agency’s concerns. US FDA is expected to state the concerns in a formal letter, expected within the next 30 days.”
Sun Pharma acquired deuruxolitinib when it bought Concert Pharmaceuticals for $576 million earlier this year.
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.The company said, “The agency has placed the IND on partial clinical hold, due to the potential for thrombotic events, and are requiring that subjects currently on the 12 mg BID dose in the OLE studies to discontinue that dose. There have been no thrombotic events reported to date for the 8 mg BID dose and US FDA has not placed the 8 mg BID dose on hold. We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies.”
It added, “No thromboembolic events were observed during Phase-2 or Phase-3 trials, and we remain confident in deuruxolitinib’s potential to treat patients with Alopecia Areata and will work closely with the US FDA to address the agency’s concerns. US FDA is expected to state the concerns in a formal letter, expected within the next 30 days.”
Sun Pharma acquired deuruxolitinib when it bought Concert Pharmaceuticals for $576 million earlier this year.