FDA to Review New Indication for Privigen
CSL Behring announced that the Food and Drug Administration (FDA) has accepted for review the clinical efficacy supplement to its Biologics License Application (BLA) for Privigen (Immune Globulin Intravenous (Human), 10% Liquid).
Privigen is a 10% liquid intravenous immunoglobulin (IVIG) stabilized with proline, a naturally occurring amino-acid. It has previously been approved by the FDA to treat chronic immune thrombocytopenic purpura (ITP).
The supplement seeks to obtain approval for a new indication to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressing disease that may cause permanent nerve damage, to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
Two studies (PRIMA and PATH) have examined the efficacy of immunoglobulin therapy in treating CIDP. Data from the Phase 3 PRIMA study suggests that Privigen may help decrease weakness and loss of motor function in people with CIDP.
“The possibilities for innovating new uses for IVIG therapy are growing and this expansion into CIDP is another way we can deliver on our promise to meet the needs of patients with rare and serious diseases,” said Charmaine Gittleson, Senior VP Global Clinical Development at CSL.
Privigen already received approval to treat CIDP in Europe in 2013.
For more information visit CLSbehring.com.