Eurartesim® begins ‘real-life’ post African registration safety and effectiveness testing

First patients enrolled in INESS observational study

03 Oct 2013

Last week, the first African patients were treated with Eurartesim® (dihydroartemisinin-piperaquine) the EMA-approved antimalarial developed by MMV and partner Sigma-Tau, as part of the INESS programme.1 INESS is a pan-African research organization funded by the Bill and Melinda Gates Foundation that conducts Phase IV effectiveness and safety studies of antimalarial drugs. In the initial stage of the programme, the medicine will be tested in four African countries – three sites in Ghana, two sites in Burkina Faso and a site each in Tanzania and Mozambique.

Working closely with INESS researchers, led by Prof. Fred Binka and Dr Bernhards Ogutu, and in-country regulatory authorities, MMV and Sigma Tau fast-tracked registration, order quantification and delivery of Eurartesim for the study sites. The medicine is now registered for use in Ghana, Burkina Faso, Tanzania and Mozambique. Sigma Tau donated the drug to support the INESS program and MMV worked with select distributors/clearing agents in the four INESS countries to obtain import licenses and to speed port clearance of the medication. 

Why are Phase IV studies important for Africa?

Quality antimalarial medicines that are submitted to stringent regulators (e.g. EMA, FDA) first must complete Phase III trials that evaluate their safety and clinical efficacy in 1500-2000 patients. Given this limited number of patients, rare adverse events (for example, those that may occur at a rate of less than one in 2000 patients) will likely not be detected. Additionally, due to strict inclusion criteria in the selection of patients for trials, the original 1500-2000 patient cohorts might not fully reflect the actual population receiving treatment.

Programmes like INESS implement Phase IV studies in the African continent to provide additional data beyond that generated in the Phase III clinical programme. They help assess the effectiveness and safety of new malaria treatments, and can contribute to evaluating the cost effectiveness of new medications when used in local settings.

“Even after a medicine has been registered internationally for use, it is important to continue gathering data on how it works, particularly in ‘real-life’ patient settings,” said David Reddy, CEO of MMV. “This additional information can help national malaria control programmes make the best decisions regarding the best medicines for their people.”

 

1 INDEPTH Effectiveness and Safety Studies of Anti-malarial drugs in Africa