Lactiga Gets FDA Rare Pediatric Disease Designation for CVID Therapy

Press Release • updated: Aug 14, 2023

LCTG-001 on course to be the first FDA-approved biologic from human milk

NEW BRUNSWICK, N.J., August 14, 2023 (Newswire.com) - Lactiga US, Inc., a visionary biotechnology company unlocking the therapeutic value of human milk antibodies, proudly announced today that the US Food and Drug Administration (USFDA) has granted "Rare Pediatric Disease" (RPD) designation for its biologic, LCTG-001, a mucosal antibody replacement therapy comprised of polyclonal Immunoglobulin A (IgA) for nasal administration in patients with Common Variable Immunodeficiency (CVID). This significant milestone represents a major step forward in Lactiga's mission to transform the management of rare and life-threatening immunodeficiencies, especially in pediatric patients.

"This is the start of Lactiga's ambitious mission to shift the paradigm of therapeutic antibody development from systemic to mucosal delivery, where many pathogens initially enter the body. By targeting the mucosal immune system, we can create more effective therapies that prevent infection at the point of entry, leading to a much better quality of life, especially in our most vulnerable populations," said Dr. Rikin Mehta, Lactiga Co-founder and CEO.