Ghana FDA approves Marketing Authorisation for Moxidectin

The Ghana Food and Drugs Authority (FDA) has granted marketing authorisation for moxidectin, marking a significant milestone in the fight against river blindness and other human diseases. This achievement concludes more than 25 years of research and development initiated in the 1990s by the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TDR) and Wyeth Pharmaceuticals.

Since 2011, the LIH has played a key role in the moxidectin development programme through the CCMS in collaboration with TDR. This involvement followed Pfizer’s decision to discontinue its collaboration in July 2011, after acquiring Wyeth Pharmaceuticals in 2009. Medicines Development for Global Health (MDGH) assumed the sponsorship in 2014 and obtained a priority review designation to the New Drug Application (NDA) from the US FDA in 2017.

Currently, CCMS coordinates two EDCTP (EU) funded projects, running until the end of 2025, focusing on paediatric testing (https://www.minimox.eu/) and the evaluation of biannual treatment in terms of efficacy and safety of (https://mox4oncho-multimox.net/).

MDGH’s goal has been to achieve both “stringent” regulatory authority approval (i.e. US FDA) and a key endemic country approval as the foundation for wider rollout to support national disease elimination efforts with the highest standards of scientific rigour

Mark Sullivan, Managing Director of MDGH

In November 2011, LIH took over Pfizer the data management of the Phase 3 randomized clinical trial ongoing in Ghana, Liberia and the Democratic Republic of the Congo (DRC). It has been a challenging activity to transfer the trial data from a proprietary-based to a vendor-based system. CCMS properly analysed and reported trial data that passed an FDA inspection in Geneva in early April 2018.

CCMS supports research in the most Neglected tropical diseases since its inception in 2009. It is tremendous that its expertise in clinical data management and statistical methodology is a pivotal activity that international partners such as WHO/TDR or MDGH have been acknowledging throughout all these years in order to provide foundations for implementation of new treatments for the most in need

Michel Vaillant, Head of CCMS

Finally, this milestone highlights the success of a not-for-profit pharmaceutical company model. For the first time, a not-for-profit company has achieved regulatory approval to deliver a completely novel medicine to a country, without the involvement of a multinational pharmaceutical company or generic company partner. It is however not a first for CCMS as it has also been involved in fixed Artesunate combinations development against Malaria that were pre-qualified by WHO on the essential list of medicine. Please find below the formal announcement about the Ghana FDA approval, also available on MDGH website, linked here