Sun Pharma among top Nifty losers after US regulator puts partial clinical hold on Deuruxolitinib drug

The US regulator is expected to state the concerns in a formal letter which is expected within the next 30 days.

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Shares of Sun Pharmaceutical Industries fell over a percent on May 2 as the US Food and Drug Administration (FDA) put a partial clinical hold on its application for an experimental dermatological drug due to the potential of thrombotic events.

“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,” the company said in a regulatory filing. “As a result, the agency has placed the drug on partial clinical hold, due to the potential for thrombotic events,” it added.

At 12:12 pm, shares of the company were trading 1 percent lower at Rs 976.65 on the BSE.

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No thromboembolic events were observed during Phase-2 or Phase-3 trials, the company said while adding that it remains confident in deuruxolitinib’s potential to treat patients with Alopecia Areata. The US regulator is expected to state the concerns in a formal letter which is expected within the next 30 days.

Concert Pharmaceuticals is developing deuruxolitinib, an oral inhibitor of Janus kinases JAK1 and JAK2, as a potential treatment for Alopecia Areata, the company’s website read.

The company completed the acquisition of Concert Pharmaceuticals on March 6 which led to the addition of Deuruxolitinib to its global dermatology portfolio. The cost of acquisition was $576 million ($8 per share).