Posted by Michael Wonder on 25 Apr 2019
La Jolla Pharmaceutical announces U.S. FDA’s grant of breakthrough therapy designation for LJPC-0118 for the treatment of severe malaria
24 April 2019 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options for patients suffering from severe malaria.
La Jolla Pharmaceutical today announced that the US FDA has granted breakthrough therapy designation for the new investigational drug product, LJPC-0118, for the treatment of severe malaria.
La Jolla plans to file a new drug application 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 randomised, controlled, clinical studies.
