Latest news with #RiametBaby
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.
CNN
09-07-2025
- Health
- CNN
First malaria drug for newborns and young infants expected to be approved in Africa within weeks
The approval of the first malaria treatment for newborns and young infants could lead to imminent widespread use in Africa, drugmaker Novartis said Tuesday. The drug, known as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in babies weighing between 2 kilograms (4 pounds, 6 ounces) and 5 kilograms (11 pounds) and is formulated to be easy for them to take, Novartis said. Coartem Baby already has approval in the West African nation of Ghana and Novartis said it now expects eight African countries to grant their own approvals within 90 days. The countries – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – also participated in the assessment of the drug. Vas Narasimhan, chief executive of Novartis, said in a news release that this first clinically proven malaria treatment for newborns and young babies ensures 'even the smallest and most vulnerable can finally receive the care they deserve.' Until now, the smallest babies have been treated for malaria, a potentially deadly disease spread by mosquitoes, with medications designed for older children. Novartis, the Swiss pharmaceutical corporation behind the newly approved drug, says this can expose newborns to the risk of overdose and toxicity. 'Most clinical trials have historically excluded babies under six months old,' Novartis spokesman Ruairidh Villar told CNN. There were 263 million cases of malaria and 597,000 deaths in 2023 – nearly all of them in Africa, according to World Health Organization data. Children under the age of 5 accounted for about three in four malaria deaths in the region. The medicine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Switzerland-based not-for-profit organization. Novartis told CNN that it plans to 'roll out the medicine in the coming weeks on a largely not-for-profit basis.' 'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,' said Martin Fitchet, chief executive of MMV. 'The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.'
CNN
09-07-2025
- Health
- CNN
First malaria drug for newborns and young infants expected to be approved in Africa within weeks
The approval of the first malaria treatment for newborns and young infants could lead to imminent widespread use in Africa, drugmaker Novartis said Tuesday. The drug, known as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in babies weighing between 2 kilograms (4 pounds, 6 ounces) and 5 kilograms (11 pounds) and is formulated to be easy for them to take, Novartis said. Coartem Baby already has approval in the West African nation of Ghana and Novartis said it now expects eight African countries to grant their own approvals within 90 days. The countries – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – also participated in the assessment of the drug. Vas Narasimhan, chief executive of Novartis, said in a news release that this first clinically proven malaria treatment for newborns and young babies ensures 'even the smallest and most vulnerable can finally receive the care they deserve.' Until now, the smallest babies have been treated for malaria, a potentially deadly disease spread by mosquitoes, with medications designed for older children. Novartis, the Swiss pharmaceutical corporation behind the newly approved drug, says this can expose newborns to the risk of overdose and toxicity. 'Most clinical trials have historically excluded babies under six months old,' Novartis spokesman Ruairidh Villar told CNN. There were 263 million cases of malaria and 597,000 deaths in 2023 – nearly all of them in Africa, according to World Health Organization data. Children under the age of 5 accounted for about three in four malaria deaths in the region. The medicine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Switzerland-based not-for-profit organization. Novartis told CNN that it plans to 'roll out the medicine in the coming weeks on a largely not-for-profit basis.' 'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,' said Martin Fitchet, chief executive of MMV. 'The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.'
CNN
09-07-2025
- Health
- CNN
First malaria drug for newborns and young infants expected to be approved in Africa within weeks
The approval of the first malaria treatment for newborns and young infants could lead to imminent widespread use in Africa, drugmaker Novartis said Tuesday. The drug, known as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in babies weighing between 2 kilograms (4 pounds, 6 ounces) and 5 kilograms (11 pounds) and is formulated to be easy for them to take, Novartis said. Coartem Baby already has approval in the West African nation of Ghana and Novartis said it now expects eight African countries to grant their own approvals within 90 days. The countries – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – also participated in the assessment of the drug. Vas Narasimhan, chief executive of Novartis, said in a news release that this first clinically proven malaria treatment for newborns and young babies ensures 'even the smallest and most vulnerable can finally receive the care they deserve.' Until now, the smallest babies have been treated for malaria, a potentially deadly disease spread by mosquitoes, with medications designed for older children. Novartis, the Swiss pharmaceutical corporation behind the newly approved drug, says this can expose newborns to the risk of overdose and toxicity. 'Most clinical trials have historically excluded babies under six months old,' Novartis spokesman Ruairidh Villar told CNN. There were 263 million cases of malaria and 597,000 deaths in 2023 – nearly all of them in Africa, according to World Health Organization data. Children under the age of 5 accounted for about three in four malaria deaths in the region. The medicine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Switzerland-based not-for-profit organization. Novartis told CNN that it plans to 'roll out the medicine in the coming weeks on a largely not-for-profit basis.' 'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,' said Martin Fitchet, chief executive of MMV. 'The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.'
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.
