RE: Lupuzor auto-immune potential25 Jun 2018 23:20
Nothing new, more companys are adavnced in treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Why make out Lupuzor is able to treat CIPD and a break through, when so far behind -hizentra and its FDA approved
FDA and EU Approved
https://www.medscape.com/viewarticle/885924
KYOTO, Japan — Subcutaneous (SC) immunoglobulin offers several benefits compared with intravenous (IV) infusion as maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), including medical, personal, and possibly financial advantages, a new study suggests.
IV immunoglobulin is an established treatment for CIDP, but infusions have to be administered by a healthcare professional whereas at-home treatment with SC immunoglobulin can offer increased autonomy, convenience, and quality of life for patients, as well as potential cost savings. The SC route may also provide more stable immunoglobulin levels.
However, weekly SC administration has not previously been studied in CIDP in an adequately powered randomized clinical trial with appropriate disability outcome measures, said Ivo van Schaik, MD, PhD, University of Amsterdam Academic Medical Center, the Netherlands, so the Polyneuropathy and Treatment with Hizentra (PATH) trial (NCT01545076) trial was designed for this purpose.
The results were presented here at the XXIII World Congress of Neurology.
https://www.cslbehring.com/vita/newsroom/20180315-hizentra-approved-for-cidp-in-europe
FDA Approves Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
First and only subcutaneous immunoglobulin (SCIg) approved for the treatment of CIDP based on the largest controlled clinical study in CIDP
16 Mar 2018
March 16, 2018 – Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) approved Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase III PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.
“This new FDA approval for Hizentra marks a pivotal milestone for patients struggling with the disabling neurological effects of CIDP,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “As the first and only subcutaneous immunoglobulin therapy approved to treat CIDP, and studied in the largest controlled clinical trial for CIDP, Hizentra offers patients a more convenient treatment option with proven efficacy and the flexibility and freedom to self-