Case Study: Research and Development

ASAQ Winthrop Risk Management Plan, Sanofi


ASAQ Winthrop is a fixed-dose combination of artesunate and amodiaquine developed through a partnership between Sanofi and the Drugs for Neglected Diseases initiative (DNDi) to fight malaria. It is registered in 33 countries (30 in Africa, including Morocco where ASAQ Winthrop is manufactured).

Sanofi and DNDi wanted to ensure that appropriate safety and effectiveness data regarding their antimalarial medicine is available. They designed a Risk Management Plan (RMP) to proactively gather data, based on the realization that industrialized countries could not be expected to have pharmacovigilance data and that systems designed to gather such data in Sub-Saharan Africa were not sufficiently operational. This RMP currently comprises 23 clinical studies in 19 countries, primarily in Africa, each of which documents different aspects of ASAQ Winthrop safety and efficacy.

Lessons Learned?

Given our expertise as manufacturers of innovative medicines, our RMP demonstrates our commitment to document, through the collection of high-quality data, the safety and efficacy of our medicines when they are used in real-life situations. This RMP, almost entirely set up in Sub-Saharan Africa, is also an important tool to help build capacity in pharmacovigilance, using methods that are suited to African countries’ needs and resources. It is the first RMP ever submitted, in 2009, to the World Health Organization.

Results to Date?

The objective of this RMP is to gather data for at least 20,000 malaria episodes treated with ASAQ Winthrop, in order to be able to detect rare adverse events. Over the period of analysis, a cumulative total of 13 clinical studies were completed, bringing the number of patients to more than 8,000 and the number of malaria cases pooled in Sanofi’s databases to more than 10,000 episodes. Importantly, agreements were signed with two academic institutions to enable an independent analysis of the collected efficacy and safety data: with the Oxford University–based Worldwide Antimalarial Resistance Network (WWARN) and the Liverpool School of Tropical Medicine ACT Consortium (ACT stands for “artemisinin-based combination therapy”).

The data available to date show that ASAQ Winthrop maintains its efficacy over time. Its efficacy has not been observed to decrease, and no unexpected adverse events have been documented. We continue to collect data in order to reach our objective of treating at least 20,000 malaria episodes with ASAQ Winthrop.

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