The FDA today approved an intravenous injection drug to treat low blood pressure in adult patients with septic shock.
The drug, Giapreza, is made by La Jolla Pharmaceutical (NSDQ:LJPC) and was given priority review by the FDA.
“Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death,” Dr. Norman Stockbridge, director of the cardiovascular and renal products division in the FDA’s Center for Drug Evaluation and Research, said in prepared remarks. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies.”
In a 321-patient trial, Giapreza more effectively increased blood pressure in shock patients compared to a placebo.
The drug can cause blood clots in arteries and veins, including deep venous thrombosis, the FDA cautioned, so doctors should give prophylactic treatment for blood clots alongside Giapreza.
“We appreciate FDA’s rapid review and approval of Giapreza and are especially grateful to the patients, families and dedicated critical care teams who made the development of Giapreza possible,” Dr. George Tidmarsh, La Jolla’s president & CEO, said in a statement. “We look forward to bringing this new treatment option to the many critically ill patients suffering from septic or other distributive shock.”
LJPC shares were trading at $31.46 apiece in mid-morning activity today, up 11%.
