Clairyg (intravenous normal human immunoglobulin) / LFB SA - LARVOL DELTA

Long-Term Purity Profile of IQYMUNE®: A Direct Result of Quality by Design (ICNMD 2026) - "The sustained, exceptional purity of IQYMUNE® over time is a direct result of its foundational Quality by Design development. This demonstrates that a systematic QbD approach successfully builds and maintains high, consistent product quality throughout a product's lifecycle."

Real-world experience with CLAIRYG® 50 mg/mL (intravenous immunoglobulin) in children under 12 years with primary immunodeficiency or immmune thrombocytopenia: a post-approval safety study. (PubMed, Front Pediatr) - "Clairyg® was well tolerated and allowed for control of serious bacterial infection in PID and serious bleeding in ITP, which are the main complications in these respective pediatric disorders. No new safety signal was detected in children less than 12 years-old in real-life conditions of use."

Journal • Real-world • Real-world evidence • CNS Disorders • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Pain • Pediatrics • Primary Immunodeficiency • Thrombocytopenia • Thrombocytopenic Purpura

In vitro comparison between different 10% intravenous immunoglobulin preparations (DGHO 2021) - "Material and Purity profile and biological characteristics of IqY mune® were compared to other marketed 10% IVIg (Privigen®, Octagam®, Gamunex®, and Kiovig®). Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The IqYmune manufacturing process developed with a QbD approach has generated a 10% IVIg having a higher level of quality and enhanced safety profile while maintaining a high level of efficacy."

Preclinical • Hypotension

ICAR: Polyvalent Immunoglobulin in COVID-19 Related ARds (clinicaltrials.gov) - P3; N=146; Completed; Sponsor: Centre Hospitalier St Anne; Recruiting ➔ Completed; Trial primary completion date: Apr 2021 ➔ Nov 2020

Trial completion • Trial primary completion date • Acute Respiratory Distress Syndrome • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • CD38 • CD4 • CD8 • CRP

ICAR: Polyvalent Immunoglobulin in COVID-19 Related ARds (clinicaltrials.gov) - P3; N=138; Recruiting; Sponsor: Centre Hospitalier St Anne; Trial completion date: Aug 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Apr 2021

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP

An international multicenter efficacy and safety study of IQYMUNE® in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study. (PubMed, J Peripher Nerv Syst) - "These results demonstrate that IqYmune® is an effective and well-tolerated treatment in patients with CIDP."

Clinical • Journal • Hematological Disorders • Pain

IqYmune® is an effective maintenance treatment for multifocal motor neuropathy: a randomised, double-blind, multicenter cross-over non-inferiority study versus Kiovig® - The LIME Study. (PubMed, J Peripher Nerv Syst) - "No thromboembolic events nor hemolysis nor renal impairment were observed. In this first clinical trial comparing two IVIg brands for maintenance treatment of MMN, efficacy and tolerability of both brands were similar."

Clinical • Head-to-Head • Journal • Complement-mediated Rare Disorders • Gene Therapies • Hematological Disorders • Pain • Renal Disease

ICAR: Polyvalent Immunoglobulin in COVID-19 Related ARds (clinicaltrials.gov) - P3; N=138; Recruiting; Sponsor: Centre Hospitalier St Anne; Not yet recruiting ➔ Recruiting

Enrollment open

ICAR: IgIV in COVID-19 Related ARds (clinicaltrials.gov) - P3; N=138; Not yet recruiting; Sponsor: Centre Hospitalier St Anne

New P3 trial