Novartis launches first malaria drug for babies
By Ottilie Salwey
Novartis, a leading Swiss pharmaceutical company, has successfully completed the CALINA series of clinical trials in eight African countries for a new malaria drug designed specifically for infants.
The trials were funded by Medicines for Malaria Venture and conducted in Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, countries that together account for 47 percent of global malaria deaths.
The drug, Cortem Baby, has now been approved by Swiss health authorities, and the countries involved in the trials are expected to issue swift approvals to facilitate its rollout.
In 2023, malaria claimed over 600,000 lives worldwide. In some sub Saharan African countries, children accounted for up to 75 percent of those deaths. The disease disproportionately affects newborns and infants weighing under 5 kg, who may contract placental malaria or become infected through mosquito bites.
Historically, clinical data for this age group has been scarce, as newborns are often excluded from antimalarial drug trials.
Prior to Cortem Baby, treatment options for these infants involved using medications formulated for older children, posing a serious risk of overdose due to underdeveloped liver function. The new drug is a dissolvable tablet that can be mixed into breast milk or other liquids. It delivers a safe dose of artemether lumefantrine adapted to the metabolic needs of young infants.
Novartis CEO Vas Narasimhan stated the drug will “ensure even the smallest and most vulnerable can finally receive the care they deserve.”
The drug’s approval comes at a challenging time for global vaccination initiatives. Gavi, the Vaccine Alliance, which subsidizes key global immunization campaigns, has faced criticism in 2025 for what some see as a conservative approach to malaria vaccine rollout.
Justin Sandefur of the Center for Global Development has been among those calling for a shift in Gavi’s strategy. Currently, Gavi focuses on steady, maintainable purchasing and emphasizes booster programs for previously vaccinated populations before expanding coverage. Its goal for the coming year is to save 180,000 children’s lives.
However, critics argue this target lacks ambition. They urge Gavi to purchase larger volumes of available vaccines and push to save even more lives. Funding remains a core constraint. In June, a summit hosted by the EU and the Gates Foundation in Brussels secured USD9 million in new funding, substantial, but still short of Gavi’s USD11.9 million target for 2025. Additionally, Gavi lost a major funding stream when USAID cut all support during the Trump administration, creating a significant shortfall.
In response to this global funding climate, Novartis has pledged to launch Cortem Baby on a nonprofitbasis. While this marks a hopeful step in the battle against malaria, it also positions Novartis strategically within the global malaria treatment market. The company stands to benefit from potential grants, tax incentives, and future partnerships with organizations like Gavi.
