Trials & Filings

La Jolla Pharma Gets Breakthrough Designation for Malaria Treatment

NDA Planned for LJPC-0118 for 4Q19

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By: Kristin Brooks

Managing Editor, Contract Pharma

La Jolla Pharmaceutical Company was granted Breakthrough Therapy designation by the FDA for the New Investigational Drug Product, LJPC-0118, for the treatment of severe malaria. The Breakthrough Therapy designation aims to expedite the development and review of drugs intended to treat serious or life-threatening conditions. To qualify, preliminary clinical evidence must demonstrate substantial improvement over currently available therapy on at least one clinically significant endpoint. “We...

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