An article in Globe Newswire quotes National Institute of Health statistics for malaria as being between 300 to 500 million cases worldwide resulting in 1.5 to 2.7 million deaths annually.
People living in 91 countries, representing half of the population of the world, are at high risk. The highest incidents, ninety percent of malaria cases, occur in sub-Saharan Africa with a death rate from malaria of ninety-two percent (mostly children).
Global travel has added to the spread of malaria. Travelers account for approximately ten to thirty thousand cases of malaria each year. To date, there is no FDA approved therapy for malaria in the U.S.
The Changing Landscape
La Jolla Pharmaceutical is beginning to make changes to that medical landscape with its recent FDA grant for its investigational drug LJPC-0118 to treat severe malaria. LJPC-0118 targets Plasmodium falciparum, one of the four species of malaria. Plasmodium falciparum thus far has been drug resistant. Due to increased travel by people from industrialized nations, Plasmodium falciparum is now found in most parts of the world.
Malaria strikes mostly in the world’s subtropical and tropical regions. Its origin is most commonly from a parasite called Plasmodium falciparum (P. falciparum). A human who is bitten by a female mosquito infected with P. falciparum is almost certain to contract malaria. Some infections may occur after receiving blood transfusions, and sharing needles, or it may be transmitted at birth.
Malaria is the primary cause of disease and death among pregnant women and children in most developing countries.
Malaria can be mild (uncomplicated) or severe (complicated). Mild cases can be cured if diagnosed early, treated with antimalarial drugs, and extensive use of bed nets sprayed with insecticide. Additional information about malaria is available here.
About Severe Malaria
A non-immune person infected with P. falciparum does not initially exhibit signs of a severe illness. Complications, such as fever, shock, and chills can occur within several weeks if left untreated. Delirium is often the result of infections in the central nervous system followed by the patient lapsing into a coma.
However, if the patient is fortunate and receives immediate, adequate diagnosis and treatment, symptoms of falciparum malaria may be resolved in three to seven days.
La Jolla Pharmaceutical Company
The FDA reviews drugs that are being developed as a therapy for conditions that are life-threatening. If upon results from a clinical trial, the drug exhibits significant improvement over current therapy for at least one endpoint, the FDA will grant the experimental drug Breakthrough designation. The criteria for final FDA approval remains the same.
In two clinical trials, the pharmaceutical ingredient in LJPC-0118 demonstrated its superiority over quinine in reducing mortality in patients with severe falciparum malaria infections.
The FDA grant of Breakthrough Therapy Designation for LJPC-0118 brings La Jolla pharma to the next step, which is to file an NDA (New Drug Application) with the FDA in the latter part of 2019.