La Jolla Pharmaceutical Co. says a trend toward overall survival in hypotension patients is a nice result for LJPC-501, but not needed for an upcoming filing. Under a special protocol assessment (SPA) with the US FDA, the company is now on track to file an NDA in the second half of this year, with hopes of securing priority review, based on meeting the primary endpoint related to blood pressure increase in patients with catecholamine-resistant hypotension (CRH) in the pivotal ATHOS-3 study.
Survival Benefit For Hypotension Shock Drug Nice But Not Needed By FDA, La Jolla Says
La Jolla Pharmaceutical's angiotensin II drug LJPC-501 is on track for NDA via SPA this year, after meeting blood pressure increase primary endpoint in ATHOS-3, but also showing a trend toward an overall survival benefit.
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