ARG and ADMA Biologics Celebrate FDA Approval of Bivigam for Pediatric Population
March 18, 2024Atlantic Research Group, a pioneer in the immunology space since 2004, proudly announces the FDA approval of Bivigam for pediatric patients aged 2 years and older, a significant milestone achieved through our collaborative partnership with ADMA Biologics. Since our inception, ARG has championed an individualized approach to optimizing development programs in immunology, focusing on IgG replacement therapy for Primary Immunodeficiency Disease (PID) in both adult and pediatric populations. Our commitment to excellence in research and development has paved the way for groundbreaking advancements in the field.
In 2017, ARG embarked on a collaborative journey with ADMA Biologics, marking the beginning of a fruitful partnership dedicated to advancing therapies in the PID space. Together, our teams tackled various challenges head-on, demonstrating unwavering dedication and expertise:
Our strong working relationship with ADMA Biologics was forged in:
- Overcoming enrollment hurdles for pediatric patients requiring intravenous administration of study medication.
- Ensuring patient retention throughout the study to facilitate comprehensive pharmacokinetics analysis.
- Developing tailored tools and strategies to streamline the clinical trial experience for parents and their children.
- Leveraging ARG's extensive network of relationships with investigators and coordinators, cultivated over years of dedicated service.
The culmination of our collective efforts led to the successful completion of a pivotal study, ultimately resulting in the FDA's approval of Bivigam for pediatric use in December 2023.
"We are immensely proud of the collaborative spirit and dedication demonstrated by both ARG and ADMA Biologics throughout this journey," said Brad Whitlow, Director, Project Operations at ARG. "This FDA approval allows another treatment option for pediatric patients with Primary Immunodeficiency Disease, and we look forward to continuing our partnership to bring innovative therapies to those in need.”
The approval of Bivigam showcases the power of meaningful collaboration and represents ARG's unwavering commitment to advancing healthcare solutions in immunology.
For more information about ARG and our groundbreaking work in immunology, visit https://atlanticresearchgroup.com/expertise/immunology/.
