Xembify (subcutaneous normal human immunoglobulin 20%) / Grifols - LARVOL DELTA

Pharmacokinetics, efficacy, and safety of weekly/biweekly dosing of Xembify® in treatment-experienced patients, and loading/maintenance dosing in treatment-naïve patients with primary immunodeficiency (CIS 2024) - "Pharmacokinetics of biweekly IGSC-20% administration wasnoninferior to weekly administration in treatment-experienced PIDpatients. Biweekly IGSC-20% was as efficacious in preventing SBIs,infections, and hospitalizations for infections compared to weekly, andboth produced increased treatment satisfaction. Loading/maintenancedosing in naïve patients was shown to be safe and effective."

Clinical • PK/PD data • Immunology • Infectious Disease • Primary Immunodeficiency

Surveillance of anti-SARS-CoV-2 antibodies in plasma pools and in immunoglobulin medicinal products manufactured since 2020 has shown high neutralizing activity against SARS-CoV-2 and current variants (CIS 2023) - "Methods Healthy donors plasma pools collected in the US and Europe, and the subsequent intravenous (Flebogamma DIFand Gamunex-C, Grifols) and subcutaneous (Xembify, Grifols) IgG manufactured batches were followed from March 2020...Intravenous and subcutaneous IgG products efficiently neutralized the current circulating VOC, Omicron BA.5. Further research is warranted to assess whether a clinical protective titer against SARS-CoV-2 and passive immunization is achieved in patients with immunodeficiencies treated with IgG products."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=386 | Recruiting | Sponsor: Grifols Therapeutics LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=386 | Not yet recruiting | Sponsor: Grifols Therapeutics LLC

New P3 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (clinicaltrials.gov) - P4 | N=33 | Completed | Sponsor: Grifols Therapeutics LLC | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (clinicaltrials.gov) - P4; N=33; Active, not recruiting; Sponsor: Grifols Therapeutics LLC; Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Primary Immunodeficiency

A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency. (PubMed, J Clin Immunol) - "IGSC 20% demonstrated efficacy and good safety and tolerability in subjects with PI."

Clinical • Journal • PK/PD data • Immunology • Infectious Disease • Primary Immunodeficiency

Product Theater 1 - Grifols USA, LLC (ACAAI 2021) - "This process yields maximum IgG and maximum monomeric activity for proven efficacy and tolerability in the treatment of patients with PIDD, ages 2 years and older. Supported by Grifols USA, LLC, Booth #718."

Immunology • Primary Immunodeficiency

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (clinicaltrials.gov) - P4; N=31; Recruiting; Sponsor: Grifols Therapeutics LLC; Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Primary Immunodeficiency

"FDA OKs Immunoglobulin Xembify for Primary Immunodeficiencies https://t.co/Hi7jZnwxpF via @medscape" (@sueekay)

Immunology • Primary Immunodeficiency