Human immunoglobulin G

Hansa Biopharma's imlifidase improved motor function in GBS patients, with a median time to independently walk of 16 days after a single dose. Patients treated with imlifidase and IVIg returned to walking six weeks sooner than those treated with IVIg alone, highlighting imlifidase's potential in treating GBS.

DelveInsight's 'Respiratory Syncytial Virus Pipeline Insight, 2024' report details 50+ companies developing 50+ therapies, including Nirsevimab, Sisunatovir, and RSVpreF, across various stages of clinical trials. Key companies include GSK, Pfizer, and Sanofi, with recent successes like GSK's Arexvy vaccine and MSD's clesrovimab. The report covers mechanism of action, route of administration, and market dynamics.

A randomized, double-blind, phase III clinical trial (Aug 2019–Oct 2021) in Iran compared Xacrel (300 mg, then 600 mg every 24 weeks) to Ocrevus (same regimen) in MS patients. Primary outcome was ARR reduction equivalence at week 48. Secondary outcomes included disability progression, relapse-free patients, MRI lesion changes, and safety assessments. The study adhered to ethical and regulatory standards.

The immunoglobulin market, valued at US$ 13.36 billion in 2023, is projected to reach US$ 28.70 billion by 2034, driven by its use in treating immunodeficiency and other applications. Key growth factors include immunodeficiency disorders, infections, and thrombocytopenia. North America leads with a 46% share, while Asia-Pacific is expected to grow fastest due to increased health spending and prevalence of autoimmune diseases. Recent advancements include subcutaneous injection therapies and acquisitions by major pharmaceutical companies.

A study links chronic low-grade inflammation, indicated by higher leukocytes, haptoglobin, and C-reactive protein, to increased risk of depression, anxiety, and stress-related disorders. Lower immunoglobulin G levels also correlated with mental health disorders. The findings suggest long-term inflammatory processes may identify high-risk individuals.

Grifols' Xembify®, a 20% subcutaneous immunoglobulin, received FDA approval for an expanded label to include treatment-naïve patients with primary humoral immunodeficiencies (PI), becoming the first 20% SCIg with this extended label. The approval includes biweekly dosing, supported by phase 4 clinical trial data showing non-inferiority in total Ig levels compared to weekly administration. No unique safety issues were identified, and the tolerability profiles were consistent between biweekly and weekly administration. The phase 4 trial was a multicenter, single-sequence, open-label study that included 27 subjects across 18 U.S. sites.