Latest news with #Swissmedic
Malay Mail
10-07-2025
- Health
- Malay Mail
Switzerland approves first malaria drug for newborns under 5kg
GENEVA, July 10 — Switzerland's health regulator Swissmedic granted marketing authorisation on Tuesday for Novartis Riamet Baby, also known as Coartem Baby, a novel antimalarial medicine specifically designed for infants weighing two to five kg, reported Xinhua. In a statement, Swissmedic said the authorisation procedure involved close collaboration with national regulatory authorities from eight African countries. The World Health Organisation (WHO) Global Malaria Programme also participated in the scientific assessment. The next step is to ensure timely national access after the collaborative assessment. Before the introduction of Coartem Baby, there was no approved malaria treatment for infants weighing less than 4.5 kg. As a result, these newborns were often treated with formulations intended for older children, which may increase the risk of overdose and toxicity, said Novartis. The new treatment, 'ensuring even the smallest and most vulnerable can finally receive the care they deserve,' is dissolvable, including in breast milk, and has a sweet cherry flavour to make it easier to administer. According to the World Malaria Report 2024 published by the WHO, the African Region accounted for about 94 per cent of malaria cases and 95 per cent of malaria deaths globally in 2023, with 76 per cent of all deaths in this region consisting of children under the age of five. — Bernama-Xinhua
New Indian Express
10-07-2025
- Health
- New Indian Express
Switzerland approves first malaria drug for infants
CHENNAI: Swiss-pharma major Novartis AG said early this week that its pediatric malaria treatment, Coartem Baby, received regulatory approval from Swissmedic, Switzerland's national medicines regulatory authority. This marks a milestone in global health, as this Novartis drug is the world's first malaria treatment specifically developed for newborns and infants weighing between 2 and 5 kilograms. Coartem Baby is a reformulation of the existing Coartem (artemether-lumefantrine) combination therapy. The new formulation was developed through a collaboration between Novartis and the Medicines for Malaria Venture (MMV), with support from the PAMAfrica consortium. The clinical development program was co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The approval was based on positive data from the Phase II/III CALINA study, which demonstrated that Coartem Baby has a pharmacokinetic profile suitable for infants under 5 kilograms and exhibits good efficacy and safety. Global Health Impact Malaria remains one of the world's deadliest diseases, particularly among children under five years old in Africa. In 2023, there were an estimated 36 million pregnancies in 33 African countries where malaria is widespread, with about one in three mothers infected with malaria during pregnancy, raising the risk of transmission to their newborns.
The Star
09-07-2025
- Health
- The Star
Swiss health regulator approves first antimalarial for infants weighing 2-5kg
GENEVA, July 9 (Xinhua) -- Switzerland's health regulator Swissmedic has granted on Tuesday marketing authorization for Novartis Riamet Baby, also known as Coartem Baby, a novel antimalarial medicine specifically designed for infants weighing 2-5kg. In a statement, Swissmedic said the authorization procedure involved close collaboration with national regulatory authorities from eight African countries. The World Health Organization (WHO) Global Malaria Program also participated in the scientific assessment. The next step is to ensure timely national access after the collaborative assessment. Before the introduction of Coartem Baby, there was no approved malaria treatment for infants weighing less than 4.5 kg. As a result, these newborns were often treated with formulations intended for older children, which may increase the risk of overdose and toxicity, according to Novartis. The new treatment, "ensuring even the smallest and most vulnerable can finally receive the care they deserve," is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer. According to the World Malaria Report 2024 published by the WHO, the WHO African Region accounted for about 94 percent of malaria cases and 95 percent of malaria deaths globally in 2023,with 76 percent of all deaths in this region among children under the age of five.
The Hindu
09-07-2025
- Health
- The Hindu
Swiss medicines authority issues first approval for antimalarial drug for treatment of infants
Switzerland's medical products authority has granted the first approval for a malaria medicine designed for small infants, touted as a breakthrough against a disease that takes hundreds of thousands of lives — nearly all in Africa — each year. Swissmedic gave a green light Tuesday for use of the medicine from Basel-based pharmaceutical company Novartis for treatment of babies with body weights between 2 and 5 kilograms (nearly 4½ to 11 pounds), which could pave the way for hard-hit African nations to follow suit in coming months. Sigificance of infant-designed version of the medicine The agency said that the decision is 'significant' in part because it's only the third time it has approved a treatment under a fast-track authorisation process, in coordination with the World Health Organization, to help developing countries access needed treatment. The infant-designed version of the medicine has already been approved for other age groups, including older children. Quique Bassat, a malaria expert not affiliated with the Swiss review, said that the disease typically becomes frequent in most-affected areas after children reach 3 to 6 months of age, and the burden of malaria in very young children is 'relatively low' compared to older kids. But access to such medicines is important to all, he said.'There is no doubt that any child of whichever age — and particularly very, very young ones or very light-weighted ones — require a treatment,' said Bassat, the director- general of the Barcelona Institute for Global Health, known as ISGlobal. Up to now, antimalarial drugs designed for older children have been administered to small infants in careful ways to avoid overdose or toxicity, in what Bassat called a 'suboptimal solution' that the newly designed medicine could help rectify. 'This is a drug which we know is safe, we know works well, and therefore it will just be available as a new version for a specific age group,' he said. Ruairidh Villar, a Novartis spokesperson, said that eight African countries took part in the assessment and are expected to approve the medicine within 90 days. The company said that it's planning on a rollout on a 'largely not-for-profit basis' in countries where malaria is endemic. The mosquito-borne illness is the deadliest disease in Africa, whose 1.5 billion people accounted for 95% of an estimated 597,000 malaria deaths worldwide in 2023, according to WHO. More than three-quarters of those deaths were among children.
The Independent
09-07-2025
- Health
- The Independent
Hope for developing world as Swiss anti-malarial for newborns approved
Switzerland's medical products authority, Swissmedic, has granted the first approval for a malaria medicine specifically designed for infants weighing between 2 and 5kg. The newly approved medication, developed by Novartis, is a lower-dose version of a tablet previously approved for older age groups. Swissmedic's decision is significant as it marks only the third time the agency has used a fast-track authorisation process, in coordination with the World Health Organization, to help developing countries access needed treatment. This development is crucial given that malaria remains the deadliest disease in Africa, accounting for 95 per cent of global deaths from the disease in 2023, with children account for over three-quarters of those deaths. While welcomed, experts highlight the importance of transparency regarding Novartis's planned 'largely not-for-profit' rollout, including pricing and distribution strategies, especially as malaria cases continue to rise and drug resistance grows.
