In a milestone for global health, Novartis has received Swissmedic approval for Coartem Baby, the world’s first antimalarial treatment tailored for newborns and infants under 4.5kg. The decision fills a long-standing therapeutic gap and reinforces the company’s commitment to diseases that fall outside the pharmaceutical industry’s traditional commercial priorities.
An Historic First for Malaria’s Most Vulnerable Patients
With the regulatory green light from Swissmedic, Novartis becomes the first pharmaceutical company to offer a malaria therapy specifically designed for the most vulnerable patients: newborns and infants. Until now, babies diagnosed with malaria were treated with drugs intended for older children, often leading to imprecise dosing that risked overdosing and toxicity in their developing systems.
Coartem Baby represents a novel formulation of the company’s established Coartem (also known as Riamet), specifically designed with optimized dosing and delivery mechanisms for infants’ unique physiological needs. The drug was developed in collaboration with Medicines for Malaria Venture (MMV), a Swiss non-profit focused on health equity, and approved under the Swiss agency’s Marketing Authorization for Global Health Products (MAGHP) pathway, which will accelerate access in low-income regions. Approval in eight African countries is expected to follow.
The stakes are enormous. Africa accounted for 94 percent of the world’s 263 million malaria cases in 2023, with children under five representing 76 percent of all malaria-related deaths there, according to the World Health Organization (WHO). “The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients,” said MMV CEO Martin Fitchet. “It’s a vital addition to the antimalarial toolbox.”
Beyond Coartem: A Deep R&D Commitment
While Coartem Baby is a critical step, it is part of a much broader push. Novartis has invested nearly USD 500 million in malaria and neglected tropical disease R&D since 2021, building what is now the most extensive pipeline in the pharmaceutical industry for these conditions. The portfolio includes four next-generation malaria therapies, such as a Phase III candidate targeting artemisinin-resistant strains and a potential single-dose cure.
This expanded commitment comes at a time of mounting concern. Global malaria efforts are under pressure from shrinking international aid, including cuts to the US President’s Malaria Initiative (PMI), while climate change expands the habitat of disease-carrying mosquitoes like Anopheles.
Rethinking the Commercial Model for Global Health Impact
Consistent with its long-standing malaria access strategy, Novartis will offer Coartem Baby on a non-commercial basis in endemic countries. Since 1999, the company has delivered more than 1.1 billion treatment courses of antimalarials, the vast majority distributed without profit.
Coartem Baby is emblematic of Novartis’ broader rethinking of how a pharmaceutical company can approach diseases outside of a purely commercial model. In 2019, Novartis merged its Global Health and Corporate Responsibility efforts into a single unit, now focused on integrating scientific discovery, access planning, and health system support.
The division targets malaria, sickle cell disease, Chagas disease, leprosy, antimicrobial resistance, and pandemic preparedness, aiming to deliver long-term, sustainable impact in low- and middle-income countries (LMICs). “Our engagement in global health is rooted in decades of commitment,” says Lutz Hegemann, president of Global Health at Novartis. “Diseases like malaria and NTDs require a different metric of success—one that prioritizes public health outcomes over financial return.”
Novartis, whose dedication to improving access has been recognized by the Access to Medicine Index where it achieved top ranking among the world’s research-based pharmaceutical firms, has recognized that addressing diseases like malaria requires a unique approach. “Certain disease areas, particularly malaria and neglected tropical diseases, fall outside the traditional commercial scope of the private sector, yet follow the same scientific and regulatory pathways,” Hegemann affirms.
For Novartis’ Global Health division, Africa also warrants a specific outlook. “It is not a region where profit-driven models are always appropriate; rather, decisions must be guided by long-term, impact-focused considerations. To reflect this, we separated Africa from our broader international operations and developed a dedicated strategy tailored to its unique needs,” Hegemann asserts.
From Donations to Sustainable Solutions
Rather than relying solely on traditional donation models, Novartis has shifted towards more sustainable, social business forms. “While the industry has historically relied on donation models to expand access, we recognize their limitations,” says Hegemann. “Donations may offer short-term relief, but they are rarely sustainable.”
The goal is not to generate profit from its Global Health unit, but to “pursue a financially balanced model where initiatives are self-sustaining and can continue delivering impact without perpetual external support.” One example is the Novartis Access programme launched in 2015, which offers chronic-disease drugs at approximately USD 1 per month to low-income countries.
Meanwhile, Novartis has integrated an access perspective into its entire drug development process. “Since 2017, we have implemented a company-wide framework that embeds access planning into early R&D, typically from Phase II onward,” says Hegemann. This includes evaluating whether a medicine is fit for deployment in diverse health systems, addressing factors such as thermal stability, affordability, and delivery mechanisms from the outset.
Collaboration remains fundamental to the company’s access work. “We do not view global health as a space for competition between companies, but rather as one where complementary efforts across sectors can collectively address a broader set of needs,” Hegemann notes. To this effect, Novartis has signed Memorandums of Understanding with Uganda, Kenya, and Tanzania for comprehensive sickle cell disease care.
“Encouragingly, we are now seeing a growing number of governments embracing ownership of their public health agendas rather than relying solely on donor-driven solutions. That local commitment is indispensable; without it, even the most robust programmes are unlikely to succeed.”
