USFDA puts on hold Sun Pharma trials on dermatological drug regimen

The US health regulator has directed Sun Pharma to stop trials of a dermatological drug with a 12 mg dose regimen as its usage could lead to blood clots.

The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (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.

As a result, the agency 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, it added.

There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing.

"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 stated.

No thromboembolic events were observed during Phase-2 or Phase-3 trials, and the company remains confident in deuruxolitinib's potential to treat patients with Alopecia Areata and will work closely with the USFDA to address its concerns, it added.

USFDA is expected to state the concerns in a formal letter, expected within the next 30 days, the drug maker noted.

Last month, USFDA directed the drug maker to take certain corrective actions at its Mohali facility before releasing further final product batches into the US market.

Shares of the company were trading 1.34 per cent down at Rs 973.55 apiece on the BSE.