SNDA to seek approval to expand the approved indication to include patients with severe hypertriglyceridemia (sHTG). SHTG is a condition that significantly increases the risk of acute pancreatitis, which is associated with repeated hospital admissions and can be fatal. A Priority Review designation accelerates FDA’s goal to take action on an application to six months, compared to 10 months under standard review.

"The recent topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies have strengthened our confidence in the potential for plozasiran to transform the treatment of patients with sHTG," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. "The acquisition of a priority review voucher potentially accelerates the process of bringing this important new medicine to patients."

Plozasiran has received regulatory approval, as REDEMPLO®, in the United States, the European Union, China, Australia, and Canada as an adjunct to diet to reduce triglycerides in adults with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), which is the most severe form of sHTG.

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