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Novartis and Medicines for Malaria Venture (MMV) announced today the launch of Coartem Dispersible, a new pediatric formulation of Coartem (artemether/lumefantrine 20 mg/120 mg), for the treatment of uncomplicated malaria in infants and children.
Coartem Dispersible contains the same amounts of artemether and lumefantrine as Coartem, the leading artemisinin-based combination therapy (ACT) in Africa, and is the first dispersible fixed-dose ACT developed especially for children.
Each year there are more than one million malaria-related deaths around the world. Nine out of ten malaria deaths occur in sub Saharan Africa, and the vast majority of malaria-related deaths occur in children. In Africa alone, a child dies every 30 seconds from malaria.
“This new Coartem Dispersible tablet can help improve treatment and compliance saving many of the more than 700,000 children under five who die each year from malaria,” said Dr Daniel Vasella, chairman and CEO of Novartis.
“I am pleased that we can provide a clearly better formulation to help ensure children with malaria receive and can take an effective therapy.”
Until now, many parents crushed bitter-tasting antimalarial tablets for their children to swallow. The new sweet-tasting Coartem Dispersible tablets disperse quickly in small amounts of water, easing administration and ensuring effective dosing for children.
“The launch of Coartem Dispersible is an important milestone in the fight against malaria and marks the culmination of several years of successful collaboration with Novartis,” said Dr Chris Hentschel, President and CEO of Medicines for Malaria Venture.
“As malaria is essentially a pediatric disease, we are hopeful that this child-friendly formulation will contribute to a reduction in child mortality in Africa, and give children back their future.”
A phase III study recently published in The Lancet showed that Coartem Dispersible provides a high cure rate of 97.8%, which is comparable to that of Coartem (98.5%). Investigators also reported that it had a good safety profile.
As part of its ongoing commitment to patients and health workers, Novartis and MMV also provide malaria case management educational programs, which include hands-on training for local healthcare workers, customised training manuals, and user-friendly packaging to ensure that Coartem Dispersible is properly used and to improve patient compliance.
Like Coartem, Coartem Dispersible will be provided to the public sector without profit to benefit those people most in need in the developing world. In addition to Swissmedic, Coartem Dispersible is approved by several regulatory authorities in Africa. These countries include Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Ghana, Guinea, Ivory Coast, Kenya, Madagascar, Mauritania, Niger, Nigeria, Senegal, Togo, and Zambia.