Certara was privileged to participate as a key member of the
Medicines Development for Global Health development team to achieve FDA
approval of moxidectin
PRINCETON, N.J.–(BUSINESS WIRE)–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
Lisa Osborne, 206-992-5245