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# La Jolla Pharma Reports Positive Data on Hypotension Drug
- URL: https://www.fdaweb.com/la-jolla-pharma-reports-positive-data-on-hypotension-drug/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:09:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138081

La Jolla Pharmaceutical Co. has reported positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension. “The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001),” the company says. “In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 \[hazard ratio=0.78 (0.57-1.07), p=0.12\] for LJPC-501-treated patients.”

On the safety side, outcomes were watched by an independent data safety monitoring board that has recommended the study continue as originally planned. The company says that 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event.

  
La Jolla says that an NDA submission is planned for the second half of the year.