Novartis on Tuesday said it had received approval in Switzerland for Coartem Baby, which it said was the first drug to treat malaria in babies and young children.
Eight African countries who participated in the assessment are now expected to issue quick approvals for the treatment, which is also known as Riamet Baby in some countries.
Novartis launched Coartem to treat malaria in 1999, with a new dose strength now designed for small babies.
The treatment is dissolvable, including in breast milk, and has a sweet cherry flavour to make it easier to administer.
The eight countries that took part in the assessment were Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda.
Around 30 million babies are born in areas of malaria risk in Africa every year, with one survey across West Africa reporting infections ranging between 3.4 percent and 18.4 percent in infants younger than six months old, Novartis said.
Malaria killed nearly 600,000 people in 2023, with Africa accounting for the vast majority of cases and deaths, according to the World Health Organization's (WHO) 2024 World Malaria Report.
The report estimated there were 263 million malaria cases globally in 2023, resulting in 597,000 deaths.
Every year, hundreds of thousands of people die from malaria, a mosquito-borne disease that remains a major global health challenge.
Malaria, caused by a parasite transmitted through bites by the female Anopheles mosquito, is described by WHO as a preventable and treatable disease.
Symptoms include fever, chills, headaches, fatigue, yellowing of the eyes and skin, seizures, and difficulty breathing.
Children under the age of five remain the most vulnerable group, accounting for 76 percent of all malaria-related deaths globally.
Africa remains the hardest-hit region, accounting for approximately 94 percent of global malaria cases and 95 percent of deaths in 2023.
The continent reported 246 million infections last year.
A new concern emerged in 2023, as mutant malaria parasites that evade standard diagnostic tests were detected in 41 countries, including Burkina Faso and Indonesia.
