La Jolla Pharmaceutical Company announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for LJPC-0118 (artesunate), an investigational treatment for severe malaria.
LJPC-118 is an investigational medication that contains the active ingredient, artesunate. According to 2 randomized, controlled, clinical studies, artesunate demonstrated superiority to quinine in reducing mortality in patients with severe falciparum malaria infection. IV artesunate is currently not FDA-approved or commercially available in the US, but it is the first-line, WHO-recommended treatment for severe malaria.
“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, MD, PhD, La Jolla’s President and Chief Executive Officer. “There are currently no approved treatments in the US 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.”
The Company plans to file a New Drug Application with the FDA in the fourth quarter of 2019.
For more information visit lajollapharmaceutical.com.