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Certara was privileged to participate as a key member of the Medicines Development for Global Health development team to achieve FDA approval of moxidectin
Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today celebrated an important milestone for its public health drug development and treatment consulting portfolio. Certara was engaged by Medicines Development for Global Health (MDGH) to be a key part of its integrated drug development team to gain US Food and Drug Administration (FDA) approval for moxidectin, an 8 mg oral treatment for river blindness (onchocerciasis) in patients aged 12 years and older.
FDA approved MDGH’s new drug application for moxidectin on June 13, 2018 and MDGH has been granted a tropical disease priority review voucher. MDGH is the first not-for-profit company to achieve FDA approval as sole sponsor and also the first not for profit awarded a priority review voucher by the FDA.
HIV, tuberculosis, malaria, neglected tropical diseases (NTD) and viral hepatitis affect billions of people around the world, and cause more than 4 million deaths each year, according to the World Health Organization (WHO). The WHO Cluster for Communicable Diseases (CDS) is charged with the prevention and treatment of these high-burden diseases. NTDs are a group of parasitic and bacterial diseases that cause substantial illness for more than one billion people globally. 149 countries and territories are affected by at least one NTD. Onchocerciasis is a NTD.
Certara partners with industry, academia, charitable foundations, regulatory bodies and governmental organizations to understand the science and population impact of these public health diseases and help create safer, more effective and more cost-efficient treatment options. To that end, Certara has developed and contributed to specific drug development tools and development programs for malaria, tuberculosis, HIV, hepatitis, neglected tropical diseases, multiple drug resistant infections and scores of rare and orphan diseases.
“The phrase, ‘Doing well by doing good,’ epitomizes Certara’s culture and philosophy as we partner with the biopharma market to address public health challenges,” said Craig Rayner, PharmD, MBA, Senior Vice President at Certara Strategic Consulting (CSC). “Onchocerciasis is the second leading cause of infectious blindness and the fourth leading cause of preventable blindness worldwide. It is endemic in some of the world’s poorest and most disadvantaged communities, affecting at least 25 million people worldwide. To have been selected by MDGH to support the development of moxidectin, an innovative and less burdensome treatment for onchocerciasis, was an honor for our team. We thank MDGH for this opportunity.”
CSC provided a variety of expertise to MDGH’s global virtual development team for moxidectin for river blindness, including membership of the development governance committee, leadership of clinical pharmacology and pharmacometrics (modeling and simulation), and support for MDGH’s translational medicine, regulatory science and strategy activities.
“FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting,” said Mark Sullivan, Founder and Managing Director of MDGH. “It takes a broad community to develop a new medicine, and the FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders and study participants.” He added, “The Certara team were (and remain) tremendous collaborators and were very much part of our team.”
MDGH secured the rights to develop moxidectin for human use from the WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) in 2015. A US $13 million investment from the Global Health Investment Fund (GHIF) enabled MDGH to complete the Phase III trial, establish quality manufacturing to support registration, conduct an additional human study to complete the clinical data package, and prepare the comprehensive registration application for the FDA for moxidectin for river blindness.
Medicines Development for Global Health is a not-for-profit biopharmaceutical company headquartered in Melbourne, Australia. Established in 2005, this unique organization is dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low- and middle-income countries. MDGH is a not-for-profit social enterprise. For additional information about MDGH, please visit www.medicinesdevelopment.com.
TDR, the Special Programme for Research and Training in Tropical Diseases, is a global program of scientific collaboration that helps facilitate, support and influence efforts to combat diseases of poverty. It is hosted by the WHO and is sponsored by the United Nations Children’s Fund, the United Nations Development Programme, the World Bank and WHO. For additional information about TDR, please visit www.who.int/tdr.
Global Health Investment Fund is a $108 million social impact investment fund designed to provide financing to advance the development of drugs, vaccines, diagnostics and other interventions against diseases that disproportionately burden low- and middle-income countries. The GHIF seeks opportunities that have a clear impact on public health in developing countries but also have value in high-income countries. For additional information about GHIF, please visit www.ghif.com.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Chief Commercial Officer
Rana Healthcare Solutions
Lisa Osborne, 206-992-5245
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