FDA accepts La Jolla's LJPC-501 for distributive shock

FDA accepted and granted Priority Review to an NDA from La Jolla Pharmaceutical Co. (NASDAQ:LJPC) for LJPC-501 (angiotensin II) to treat hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The PDUFA date for the renin-angiotensin system peptide agonist is Feb. 28, 2018.

In February, investors were quick to bid up La Jolla shares after the company reported that LJPC-501 met the primary blood pressure endpoint in the Phase III ATHOS-3 trial to treat distributive shock (see BioCentury, March 2)...