La Jolla Pharmaceutical Co. recently initiated an expanded access program (EAP) in the United States for its investigational drug LJPC-501.
According to the company, the investigational drug was developed to treat “patients with vasodilatory or distributive shock who cannot achieve target mean arterial pressure despite adequate fluid resuscitation and treatment with currently available vasopressors (a syndrome alternatively known as ‘catecholamine resistant hypotension’ or ‘clinically refractory hypotension’).”
La Jolla noted that the U.S. Food and Drug Administration facilitates EAPs to help expedite investigational medicines that could treat serious or life-threatening conditions, specifically when those conditions do not have many alternative forms of treatment.
“We are pleased to commence this expanded access program for eligible patients in the U.S.,” Dr. George Tidmarsh, president and CEO of La Jolla, said in a statement. “This EAP provides a mechanism for eligible patients to access LJPC-501 while the company is diligently working to pursue FDA approval.”
The LJPC-501 EAP is for patients 18 or older. The drug is a proprietary formulation of synthetic human angiotension II.