NEW DELHI: The US health regulator has asked Sun Pharma to stop trials on one dose of a dermatological drug, citing potential blood clots. The Mumbai-based company on Tuesday said that the US Food and Drug Administration (FDA) has put a partial clinical hold on its application for an experimental dermatological drug due to the potential of thrombotic events.
The company said that it had a teleconference call with the USFDA regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies. The USFDA has placed the investigational new drug (IND) on partial clinical hold due to the potential for thrombotic events and is requiring that subjects currently on the 12 mg dose in the OLE studies discontinue that dose, the company said.
There have been no thrombotic events reported to date for the 8 mg dose and the USFDA has not placed the 8 mg dose on hold, the drug maker said. Patients with Alopecia Areata, an autoimmune condition that results in patchy hair loss, on the 12 mg dose of the drug deuruxolitinib should discontinue its use, the FDA has told the company.
“We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies,” Sun Pharmaceutical Industries added. Last month, the USFDA had also directed the pharma firm to take certain corrective measures at its Mohali facility before releasing further final product batches into the US market.
The company said no thromboembolic events were observed during Phase-2 or Phase-3 trials, and that it is confident in deuruxolitinib’s potential to treat patients with Alopecia Areata and will work closely with USFDA to address its concerns. The USFDA is expected to state the concerns in a formal letter, expected within the next 30 days, it added.