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Investigational Drug for Severe Malaria Gets Breakthrough Therapy Designation
The FDA has granted a breakthrough therapy designation for La Jolla Pharmaceutical’s New Investigational Drug Product, LJPC-0118, for the treatment of severe malaria.
Two randomized, controlled, clinical studies demonstrated that LJPC-0118’s active pharmaceutical ingredient was superior to quinine in reducing mortality in patients with severe falciparum malaria infection. La Jolla intends to file a new drug application (NDA) in the fourth quarter of 2019 for LJPC-0118.
LJPC-0118 is an investigational product for the treatment of severe malaria. Symptoms of severe malaria include fever, chills, sweating, hypoglycemia, and shock. The disease is often complicated by central nervous system infections that may lead to delirium, which can result in coma and death.
In 2017, almost half of the world’s population was at risk of developing malaria, and just five countries contained close to half the worldwide number of malaria cases: Nigeria, the Democratic Republic of the Congo, Mozambique, India, and Uganda.
Children under 5 years of age are particularly vulnerable to the disease, accounting for 61% (266,000) of an estimated 435,000 deaths from malaria worldwide in 2017.