Latest news with #Coartem
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.
Business Insider
09-07-2025
- Health
- Business Insider
Novartis (NVS) Wins Landmark Approval for Baby Malaria Treatment
Shares in pharmaceutical giant Novartis (NVS) were lower today despite receiving regulatory approval for the first drug to treat malaria in babies and young children. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. African Approval The group said it had been given the green light in Switzerland by Swissmedic for Coartem Baby or Riamet Baby as it is known in some other countries. Eight African countries, Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda who participated in the assessment are now expected to issue quick approvals for the treatment. According to UNICEF, in 2022, there were 249 million malaria cases globally that led to 608,000 deaths in total. Of these deaths, 76% were children under 5 years of age. 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% and 18.4% in infants younger than six months old. Relentless Work Novartis launched Coartem to treat malaria in 1999, with the new dose strength now designed for small babies. The treatment is dissolvable, including in breast milk, and reportedly has a sweet cherry flavor to make it easier for children to swallow. Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap, Novartis said. Indeed, they have been treated instead with versions formulated for older children which present a risk of overdose. Novartis chief executive, Vas Narasimhan, said: 'For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most.' Is NVS a Good Stock to Buy Now? On TipRanks, NVS has a Hold consensus based on 2 Buy, 2 Hold and 1 Sell ratings. Its highest price target is $139.24. NVS stock's consensus price target is $113.45 implying a 7.10% downside.
Economic Times
08-07-2025
- Health
- Economic Times
Novartis gets approval for first malaria drug for babies and children
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. Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap, Novartis said. 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% and 18.4% in infants younger than six months old, Novartis said.
Al Etihad
08-07-2025
- Health
- Al Etihad
First infant malaria treatment receives approval: Novartis
9 July 2025 00:21 ZURICH (AFP)The first malaria treatment for newborns and young infants has received approval from Swiss health regulators, with eight African countries poised to roll the drug out rapidly, pharmaceutical giant Novartis said is a major killer in Africa, with the continent accounting for 95 percent of the 597,000 deaths from the disease worldwide in 2023, according to the World Health those deaths, about 76 percent -- more than 432,000 -- were children under five, according to the infant version of Novartis's Coartem treatment, also known as Riamet, was developed in collaboration with the Medicines for Malaria Venture (MMV), a Geneva-based organisation specialising in research and development of medicines against the disease."Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms (nine pounds 15 ounces)," Novartis said in a approval from Switzerland's health authority is for a dose designed for babies weighing two to five of the countries hit hardest by malaria -- Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda -- participated in the Swiss approval countries are now expected to approve the treatment quickly themselves, under a programme to facilitate access to medicines for low- and middle-income countries, Novartis Swiss pharmaceutical company said it would introduce the treatment "on a largely not-for-profit basis" to increase access in places where the mosquito-borne disease is endemic. An estimated 263 million people worldwide had malaria in 2023, according to the WHO.
08-07-2025
- Health
Swiss medicines authority issues first approval for antimalarial drug for treatment of infants
GENEVA -- Switzerland's medical products authority has granted the first approval for a malaria medicine designed for small infants, touted as an advance against a disease that takes hundreds of thousands of lives — nearly all in Africa — each year. Swissmedic gave a green light Tuesday for 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. 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 authorization process, in coordination with the World Health Organization, to help developing countries access needed treatment. The newly approved medication, Coartem Baby, is a combination of two antivirals. It is a lower dose version of a tablet previously approved for other age groups, including older children. Dr. Quique Bassat, a malaria expert not affiliated with the Swiss review, said 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. Dr. Bhargavi Rao, co-director of the Malaria Centre at the London School of Hygiene and Tropical Medicine, noted that malaria cases continue to rise — especially in crisis-hit countries — despite new vaccines and programs targeting the mosquitoes that spread the parasite. She said access strategies for the new medicine must include a look at where needs are greatest, and urged clarity on pricing. 'We need transparency around what Novartis' 'largely not for profit' statement means including publicly available pricing, which countries will benefit and how long for,' she wrote in an email. Still, she said it was 'significant to finally have a suitable and safe treatment for very young children — more than 20 years since WHO first pre-qualified Coartem for older age groups. She noted the announcement comes as resistance to antimalarials has been growing and many traditional donor countries have been sharply cutting outlays for global health — including for malaria programming and research. 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.
