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MMV to advance WHO-TDR’s pioneering studies on intrarectal artesunate
Partnership will work towards availability of this pre-referral treatment for children with severe malaria
14 December 2012
With recently announced support from UNITAID, MMV will be coordinating a development effort to bring a commercially manufactured version of intrarectal artesunate through the WHO prequalification process. This work will build on the pivotal studies conducted by WHO-TDR that evaluated this pre-referral treatment for severe malaria.
Severe malaria impacts an estimated 8.0 million people per year; it results from inadequately treated uncomplicated malaria and can quickly lead to death, particularly in children. In the event that recommended parenteral (injected) treatment options are not readily available, the administration of rectal artesunate (in suppository form) can buy critical time for patients in transit to treatment facilities.
WHO-TDR played a pioneering role in conducting a large scale placebo-controlled trial involving over 17,000 patients in Bangladesh, Ghana and Tanzania regarding the efficacy of pre-referral rectal artesunate. The trial demonstrated that "if patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability."
Moving forward, MMV will work with TDR and pharmaceutical partners to establish a manufacturing solution for large-scale production of intrarectal artesunate to satisfy GMP requirements and be eligible for review by the WHO Prequalification programme and regulatory authorities.
MMV acknowledges the critical work of TDR in advancing intrarectal artesunate and looks forward to partnering with them on the development of a prequalified version of this treatment.
GMP=Good Manufacturing Practice