Sanofi-aventis and Medicines for Malaria Venture (MMV) announced that they have entered an agreement to launch the largest safety and efficacy study of an antimalarial drug.
This field-monitoring program on ASAQ, a fixed-dose combination of artesunate and amodiaquine, started in CÃ´te d’Ivoire in October 2009. MMV is a not-for-profit drug research and development organization dedicated to reducing the burden of malaria.
ASAQ is the only fixed-dose combination of artesunate and amodiaquine prequalified by WHO in the treatment of Plasmodium falciparum uncomplicated malaria. ASAQ is the result of a partnership between sanofi-aventis and Drugs for Neglected Diseases initiative (DNDi) and was launched in 2007.
“We have designed an innovative field-monitoring program to assess the effectiveness and safety of ASAQ in real life conditions”, said Robert Sebbag, Vice President, Access to Medicines at sanofi-aventis. “Thanks to MMV’s support, we are now able to launch in CÃ´te d’Ivoire this large study that completes the most ambitious drug monitoring program ever launched in Africa”, he added.
Under the terms of the agreement, MMV will provide $1.5m towards the implementation of this large field-monitoring study developed by sanofi-aventis and the National Malaria Control Program of CÃ´te d’Ivoire.
Over a two-year period, approximately 15,000 patients afflicted by malaria are expected to be enrolled. All patients diagnosed with uncomplicated malaria at public health clinics in selected parts of the Agboville district (approximately 100km north of Abidjan) will receive a prescription of ASAQ. Within a week, patients will be visited at home by specially trained community health workers to assess treatment tolerability and compliance.
“Data collected in clinical trials do not always provide the full picture of a new drug’s efficacy and safety. This large CÃ´te d’Ivoire study will use innovative methods to monitor antimalarial drugs’ efficacy and safety and generate critical data,” said Dr Chris Hentschel, President and CEO of MMV.
“MMV is pleased to support this important study. The experience gained with ASAQ in the field will help us design pharmacovigilance programs for the new antimalarials in our own pipeline.”
Malaria is a fatal infectious disease that causes almost a million deaths a year of which over 90% are in Africa and 85% are children under the age of five. Most of these deaths are due to lack of access to effective antimalarials and erratic patient compliance.