Breakthrough therapy status to malaria drugJuly 5, 2019
LJPC-0118, a new investigational drug product has received the US FDA breakthrough therapy designation for the treatment of severe malaria, said La Jolla Pharmaceutical Company.
LJPC-0118 demonstrated superiority to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized trials.
Based on these results, the pharmaceutical company plans to submit a New Drug Application with the FDA in the fourth quarter of 2019.
Severe malaria is a serious and life-threatening disease without a current FDA approved therapy.
In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 200 million of these cases occurring in the African Region, and, in 2013, the global annual incidence of severe malaria was estimated to be 2 million cases.
The FDA’s Breakthrough Therapy designation is a process designated to expedite the development and review of a drug candidate.