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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La Jolla's LJPC-501 meets primary blood pressure endpoint in the Phase III ATHOS-3 vasodilatory shock trial, but data suggest benefits may not translate into clinically meaningful improvements.
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Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.