La Jolla Pharmaceutical Company Announces Launch of Expanded Access Program for LJPC-501
Wednesday, August 09, 2017
La Jolla Pharmaceutical Company, today announced that the Company has initiated an expanded access program (EAP) in the United States to provide its investigational drug, LJPC-501 (angiotensin II), to patients with vasodilatory or distributive shock who cannot achieve target mean arterial pressure (MAP) despite adequate fluid resuscitation and treatment with currently available vasopressors (a syndrome alternatively known as “catecholamine resistant hypotension” or “clinically refractory hypotension” (CRH)).
Expanded access, sometimes known as compassionate use, is an option facilitated by the U.S. Food and Drug Administration (FDA) to make available prior to regulatory approval investigational medicine(s) for the treatment of serious or life-threatening diseases or conditions where there are no ongoing clinical trials and there is a lack of satisfactory therapeutic alternatives.
“We are pleased to commence this expanded access program for eligible patients in the U.S.,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “This EAP provides a mechanism for eligible patients to access LJPC-501 while the Company is diligently working to pursue FDA approval.”
