Here is a look at infectious disease-related US Food and Drug Administration news from the week of April 21, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 21, 2019.
FDA Grants Breakthrough Therapy Designation for Investigational Drug to Treat Severe Malaria
On Wednesday, April 24, the FDA granted Breakthrough Therapy designation to La Jolla Pharmaceutical Comapny for the New Investigational Drug Product LJPC-0118 for the treatment of severe malaria.
In 2 randomized, controlled, clinical studies, the active ingredient in LJPC-0118 proved superior to quinine in reducing mortality in patients with severe falciparum malaria infection.
“We are committed to the rapid development of LJPC-0118 to help patients suffering from severe malaria, a serious and life-threatening disease without a current FDA-approved therapy. We are very pleased to receive the Breakthrough Therapy designation from the FDA and are committed to providing LJPC-0118 to patients in the US,” George Tidmarsh, MD, PhD, La Jolla’s president and CEO, said in a company statement. “This designation is a key regulatory milestone and we look forward to working closely with the FDA to further develop LJPC-0118.”
La Jolla plans to file a New Drug Application with the FDA for LJPC-0118 in the fourth quarter of 2019.
The full press release is available here.