Hizentra prevents neuromuscular disability and impairment relapse in patients with CIDP, a rare immune-mediated disorder of the peripheral nerves.
The US Food and Drug Administration (FDA) has accepted the Supplemental Biologics License application of Hizentra (subcutaneous immunogoblin (SCIG)) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
Hizentra functions as a maintenance therapy that prevents neuromuscular disability and impairment relapse in patients with CIDP, a rare immune-mediated disorder of the peripheral nerves. The condition has been known to worsen in patients over time.
The application from biotherapeutics company CSL Behring was backed by the largest-ever randomized CIDP trial, Polyneuropathy And Treatment with Hizentra (PATH). The trial was completed in March of this year, and showed Hizentra's efficacy, safety and tolerability in 2 different doses for patients previously treated with intravenous immunogoblin (IVIG) versus placebo.
Hizentra, the most prescribed SCIG in the world — and the only 20% SCIG designed with stabilizer L-proline — was administered by patients and caregivers during the study. Dose volumes up to 50 mL/site and infusion rates up to 35 mL/hour were allowed, in order to give patients treatment flexibility.
Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director of CSL Limited, said the FDA's approval is another step towards "delivering on our promise" to CIDP patients.
"We're also excited about the possibility of adding a CIDP indication for our industry-leading portfolio of immunoglobulin therapies," Cuthbertson said.
CSL Behring anticipates to have an ongoing long-term label extension study for Hizentra be completed later this year.