Regulatory FDA imposes partial hold on Sun's Concert 2 months...

FDA imposes partial hold on Sun’s Concert 2 months after $576M buyout, causing setback


Sun Pharmaceutical Industries Ltd., an Indian firm, has been directed by the U.S. Food and Drug Administration (FDA) to halt testing of a 12 mg dose of the dermatological medication deuruxolitinib due to potential risks of blood clotting.

Patients with alopecia areata who were taking the 12 mg dose have been advised by the FDA to discontinue its use, while trials involving the 8 mg dose continue as normal since no thrombotic events were reported. Sun Pharma aims to address the concerns by working closely with the FDA. The company will be communicating the  aforementioned concerns within a month. Sun Pharma acquired deuruxolitinib as part of its $576 million purchase of Concert Pharmaceuticals earlier this year.

The FDA’s concerns arose as a result of a patient suffering from a pulmonary embolism after being administered the 12-mg twice daily dose of the oral JAK1/2 inhibitor deuruxolitinib. This was part of an open-label extension to a phase 3 clinical trial for alopecia areata. 

Alopecia areata is an autoimmune disorder that causes hair loss in patients, usually from the head as well as the face.

As a result, the FDA has imposed a partial clinical hold on Sun Pharma, requiring it to halt tests on the 12-mg twice daily dose. However, patients can continue to take the 8-mg twice daily dose, and Sun Pharma is taking immediate steps to transition participants in open-label studies to the lower dose. No patients taking the 8-mg dose have suffered thrombotic events such as pulmonary embolisms. Sun Pharma plans to work with the FDA to resolve concerns raised by the pulmonary embolism and remains confident in the potential of deuruxolitinib to treat alopecia areata.

Sun Pharma’s acquisition of deuruxolitinib was part of its buyout of Concert Pharmaceuticals, a deal which has hit a stumbling block just two months after closing, following the partial hold on the development of the drug. The concerns raised by the FDA are partly due to the broader safety issues associated with the JAK class of drugs, with the European Medicines Agency recommending caution when treating patients with risk factors for blood clots in the lungs and in deep veins due to evidence that JAK inhibitors can cause thromboembolic events.

Lilly’s JAK inhibitor Olumiant, which won approval in alopecia areata last year, carries a black box warning in the U.S. due to safety issues including an increased incidence of pulmonary embolism. However, there were no cases of venous thromboembolism (VTE) in Lilly’s two phase 3 alopecia areata trials, with only one case reported in an extended safety analysis. Concert highlighted the lack of pulmonary embolisms or deep vein thromboses as a strength of its phase 3 data.

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