Dive Brief:

• Novartis won regulatory approval Tuesday of the first malaria medicine for newborns and the youngest infants, who until now had no treatment specifically available for them.
• Regulators in Switzerland cleared the pharmaceutical company’s Coartem Baby, which is a new formulation of a two-drug regimen that for years has been used against malaria in children over 2 months old. Swissmedic’s OK is for infants who weight less than 4.5 kilograms, or about 10 pounds.
• Eight African countries took part in the Swiss regulator’s assessment and are expected to issue their own approvals soon, Novartis said. The pharmaceutical company plans to launch the drug this year “on a largely not-for-profit basis in areas where malaria is endemic.”

Dive Insight:

Malaria, which is typically passed on by mosquitoes but can also be transmitted via blood transfusion and contaminated needles, can be life-threatening. Pregnant women, travelers and infants are at higher risk of severe disease.

While cases occur in tropical regions worldwide, malaria is particularly prevalent in African countries. According to a survey in West Africa cited by Novartis Tuesday, between 3% and 18% of infants younger than 6 months of age are infected with malaria.

Currently, newborns and very young infants are treated with drug formulations that are intended for older, heavier children. They also are not eligible for approved malaria vaccines and are typically excluded from clinical trials of antimalarial medicines.

Coartem Baby, which will be sold as Riamet Baby in some countries, uses a different dose and ratio of the two agents, artemether and lumefantrine, that are contained in the existing version of the drug. It was developed with the support of the Medicines for Malaria Venture, with whom Novatis has long partnered.

Umberto D’Alessandro, director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine, said in a statement provided by Novartis that previously available malaria treatments are not always appropriate for small babies. “Neonates and young infants have immature liver function and metabolize some medicines differently,” he said.

Coartem Baby is dissolvable in liquid and can be administered with breast milk.