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Lactiga Receives FDA 'Rare Pediatric Disease' Designation





Lactiga Receives FDA 'Rare Pediatric Disease' Designation for Groundbreaking Mucosal Immunoglobulin Therapy for Common Variable Immunodeficiency Disease


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.


CVID is a chronic and incurable heterogeneous immune disorder characterized by a decline in antibodies resulting in a weakened immune system and increased susceptibility to infections. Patients who suffer from CVID experience a decreased quality of life and increased risk of premature mortality compared to the general population. In its letter granting RPD designation, the FDA stated there is "sufficient information to demonstrate that increased mortality rate, developmental delay, and failure to thrive are serious or life-threatening manifestations that primarily affect children [with CVID]."


"We are thrilled to be granted the RPD designation by the FDA for our groundbreaking mucosal Immunoglobulin A therapy," expressed Lactiga's Chief Scientist, Dr. Viraj Mane. "This designation not only recognizes the significance of our research but also underscores our dedication to making a meaningful impact on the lives of young patients."


The FDA's RPD designation program is intended to encourage and accelerate innovative therapies to treat rare, life-threatening diseases that primarily affect individuals aged from birth to 18 years. By obtaining this designation, Lactiga has access to valuable incentives and support from the FDA during its development program. Upon approval of LCTG-001, Lactiga qualifies to receive a priority review voucher for any subsequent marketing application which can be sold or transferred to other companies.


About Lactiga


Lactiga is an award-winning, visionary biotechnology company committed to pushing the boundaries of medical science and improving the lives of immunodeficient patients through innovative mucosal therapies. With an unwavering focus on research and patient-centered innovation, Lactiga aims to address unmet medical needs for rare immunodeficiency diseases globally. Through groundbreaking research and strategic partnerships, Lactiga is creating a positive impact on these patients and their families.

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