US FDA Places Sun Pharma’s Alopecia Drug IND on Partial Hold

Sun Pharmaceutical Industries Ltd.’s clinical trials on alopecia areata drug candidate deuruxolitinib has been put on “partial” hold by the US Food and Drug Administration after blood clot related issues, according to an exchange filing.

• The regulator placed the company’s Investigational New Drug Application on partial clinical hold due to the potential for thrombotic events, classified as serious adverse events, in the 12 mg dose during one of the long-term Open Label Extension studies
• No such thrombotic events reported for the 8 mg dose so far and US FDA has not placed the dose on hold, Sun Pharma said ...