La Jolla Pharmaceutical Company Announces FDA’s Grant of Breakthrough Therapy Designation for LJPC-0118 for the Treatment of Severe Malaria

La Jolla Pharmaceutical Company announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the New Investigational Drug Product, LJPC-0118, for the treatment of severe malaria.

The Breakthrough Therapy designation is an FDA program designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.

“We are committed to the rapid development of LJPC-0118 to help patients suffering from severe malaria, a serious and life-threatening disease without a current FDA-approved therapy. We are very pleased to receive the Breakthrough Therapy designation from the FDA and are committed to providing LJPC-0118 to patients in the US,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “This designation is a key regulatory milestone and we look forward to working closely with the FDA to further develop LJPC-0118.”

La Jolla plans to file a New Drug Application (NDA) with the FDA in the fourth quarter of 2019 for LJPC-0118. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.