La Jolla Pharmaceutical Company was granted an Orphan Drug Designation from the FDA for the Investigational Drug Product, LJPC-0118 (artesunate), for the treatment of malaria.
 
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, artesunate, was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.
 
“The granting of orphan drug status is a significant milestone for the LJPC-0118 program and highlights the significant unmet medical need for the treatment of malaria,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “There are currently no approved treatments in the U.S. for patients with severe malaria. We are preparing to file a new drug application later this year and, upon approval, to making this front-line treatment for severe malaria available to the public.”