FDA approves Alygo (immune globulin intravenous, human-stwk) 10% Liquid to treat primary humoral immunodeficiency
GC Biopharma Corp announces that the FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI)
The Alyglo pivotal phase III clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC 5107B was a prospective, open-label, single-arm, historically controlled, multicenter phase III study to assess the efficacy and safety of GC 5107B in patients with a confirmed diagnosis of PI. The studies were conducted in the United States and Canada.
Key findings from the phase III clinical trial for patients aged 17 years and older include the following: i. A primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year. ii. The proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22 (95% one-sided upper confidence bound: 30%), which met the FDA-required prespecified end point of less than 0.40. iii. Secondary analyses were annual rate or days of other infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to infection, and days of hospitalization due to infection.
The results of the phase III trial by GC Biopharma are published in Frontiers in Immunology (2021). Dr. Elena Perez, MD., Allergy Immunologist from Allergy Associates of the Palm Beaches, and lead study investigator, said, "Alyglo will significantly impact clinical practice in the U.S. due to its strong safety and efficacy profile. It is an important treatment option for primary immune-deficient patients. This product provides additional confidence in treatment options for this important patient population."
See- Front. Immunol., 08 July 2021. Sec. Primary Immunodeficiencies. Volume 12 - 2021 https://doi.org/10.3389/fimmu.2021.707463- "Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies"- Elena E. Perez, Jacques Hébert ,Anne K. Ellis, Oral Alpan4 William R. Lumry, Ralph Shapiro, Daniel Suez, J. Fernando Mandujano, Richard L. Wasserman.
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