FDA Agrees that La Jolla Pharmaceutical Has Sufficient Data for Investigational New Drug ApplicationWednesday, March 6, 2013
The U.S. Food and Drug Administration has agreed that La Jolla Pharmaceutical Co. has enough data to support an investigational new drug application for a drug that treats patients with hepatorenal syndrome, a life-threatening form of kidney failure in patients with serious liver disease.
The drug, called LJPC-501, helps kidneys balance body fluids and electrolytes, and pre-clinical studies have shown that the drug can improve kidney function in patients with the disease.
“We are pleased that the FDA has accepted our proposal for an investigational new drug application to pursue LJPC-501 in patients with hepatorenal syndrome,” said George Tidmarsh, the company’s president and CEO, in a statement. “HRS affects a large patient population with no approved therapies. We look forward to initiating our Phase 1 study in the third quarter and hope that LJPC-501 may someday help those suffering.”
However, clinical trials still can’t begin until the company has filed the new drug application and it has been approved.