Sun Pharma said the US FDA has placed its investigational dermatology product, deuruxolitinib trials, on “partial clinical hold”, following a potential for adverse events.
The US Food and Drug Administration had placed “the IND (Investigational New Drug) 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,” Sun informed the stock exchange. Deuruxolitinib is used in treating adults with alopecia areata, a serious autoimmune dermatological disease. and the drug came into the Sun Pharma fold, following its acquisition of Concert Pharmaceuticals Inc in a $576 million deal in January.
Outlining the latest developments, Sun said, “following a recent submission to the US FDA, we had a teleconference call with the agency, regarding a pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies.”
There have been no thrombotic (blood clotting) events reported to date for the 8 mg BID dose, and the US FDA has not placed the 8 mg BID dose on hold, the company added.
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The US FDA is expected to state its concerns in a formal letter, expected in a month, Sun Pharma said. It further added it was taking steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies. “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,” it said.
Recent incidents
Late last month, Sun Pharma had received a US FDA directive for corrective action at its Mohali plant, a legacy from its Ranbaxy buy. The company had then said, it received a USFDA letter titled “consent decree correspondence/non-compliance” that directed it to take corrective actions at the said facility before releasing further final product batches into the US.
And in December last year, the company had received an import alert on its Halol plant in Gujarat. This meant that all future shipments of products manufactured at this facility would be refused admission to the US market until the facility complies with cGMP (current good manufacturing practice) standards, Sun Pharma had said. It had, however pointed out that 14 products were exluded from this import alert, subject to certain conditions.
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