Sun Pharma’s $576 million Concert Pharmaceuticals buyout has rapidly run onto the rocks. Two months after closing the deal, the Indian drugmaker has revealed (PDF) a blood clot has triggered a partial FDA hold on development of Concert’s key candidate. The blood clot, a pulmonary embolism, occurred in a patient who received the 12-mg, twice daily dose of the oral JAK1/2 inhibitor deuruxolitinib in an open-label extension to a phase 3 trial in alopecia areata, an autoimmune disease that causes hair loss. After learning of the adverse event, the FDA imposed a partial clinical hold that requires Sun to stop the 12-mg twice daily dose.
The blood clot, a pulmonary embolism, occurred in a patient who received the 12-mg, twice daily dose of the oral JAK1/2 inhibitor deuruxolitinib in an open-label extension to a phase 3 trial in alopecia areata, an autoimmune disease that causes hair loss. After learning of the adverse event, the FDA imposed a partial clinical hold that requires Sun to stop the 12-mg twice daily dose.
The blood clot, a pulmonary embolism, occurred in a patient who received the 12-mg, twice daily dose of the oral JAK1/2 inhibitor deuruxolitinib in an open-label extension to a phase 3 trial in alopecia areata, an autoimmune disease that causes hair loss. After learning of the adverse event, the FDA imposed a partial clinical hold that requires Sun to stop the 12-mg twice daily dose.