Study Finds Repeat Dosing of IVIG and PLEX Common in GBS, Resulting in Harm to Nonresponders
According to randomized controlled trials, repeat intravenous immune globulin (IVIG) dosing and plasma exchange (PLEX) followed by IVIG (combination therapy) have no additional therapeutic benefit in Guillain-Barré syndrome (GBS) nonresponders. Furthermore, the delineation between GBS and acute onset chronic inflammatory demyelinating polyneuropathy (A-CIDP) can be particularly challenging and carries therapeutic implications.
The Expanding Role of Immune Globulin Treatment in Diseases: Utilization and Growth
New research showing the therapeutic benefit of immune globulin for treating a variety of autoimmune diseases is contributing to market growth of this essential medicine.
FDA Approves Nipocalimab to Treat Sjögren’s Disease
Johnson & Johnson’s anti-FcRn antibody nipocalimab is the first investigational therapy to be granted breakthrough therapy designation by the U.S. Food and Drug Administration as a treatment for adults with moderate-to-severe Sjögren’s disease.
IVIG Reduces Symptom Severity for AGID
A new study indicates intravenous immun globulin (IVIG) therapy can reduce symptom severity for patients with autoimmune gastrointestinal dysmotility (AGID), also known as gastroparesis.
CSL Begins Enrollment for Hizentra Study for POTS
CSL Ltd. has begun enrolling U.S. patients in a Phase III late-stage randomized control trial to assess whether Hizentra subcutaneous immune globulin (SCIG) can alleviate symptoms of postural orthostatic tachycardia syndrome (POTS) — a blood circulation disorder that is one of the most common and disabling symptoms of long COVID with no approved therapies.
Addition of IVIG May Be Superior to Addition of Plasmapheresis in Corticosteroid-Resistant Optic Neuritis: Systemic Review
A meta-analysis and systematic review compared the efficacy of corticosteroids (CS) alone against CS combined with intravenous immune globulin (IVIG) or CS combined with plasmapheresis (PP) in patients with steroid-resistant optic neuritis.
Xembify Receives Expanded Label for PI Patients
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Grifols’ XEMBIFY (20% subcutaneous immune globulin [SCIG]) to include treatment-naïve patients with primary humoral immunodeficiencies (PI).
FDA Approves Epysqli, Second Biosimilar to Soliris
Samsung Bioepis’ biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
FDA Approves Yimmugo, an IVIG Product, to Treat Primary Immunodeficiencies
Biotest has received approval from the U.S. Food and Drug Administration for Yimmug to treat primary immunodeficiencies in patients 2 years and older.
The Proven Success of Immune Globulin Therapy to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Numerous studies show the efficacy of both IVIG and SCIG for treating CIDP, making these the best treatment options for this rare neurological condition.
