Latest news with #CoartemBaby
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.
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.
Time of India
09-07-2025
- Health
- Time of India
Novartis wins approval: First malaria treatment drug for newborns and babies is here
For the first time in history, newborns and very young infants have access to a malaria treatment tailored to their unique needs. On July 8, Swissmedic – Switzerland's regulatory agency – greenlit Coartem Baby (also known as Riamet Baby), marking a groundbreaking milestone. Until now, there have been no approved malaria drugs specifically for babies. Instead, they have been treated with versions formulated for older children, which presents a risk of overdose. This cherry‑flavored, breast‑milk–compatible, dispersible tablet closes a dangerous treatment gap for infants under 4.5 kg, who previously relied on doses designed for older children – raising overdose risks. Developed in collaboration with Medicines for Malaria Venture and backed by robust Phase 2/3 data, this new therapy is poised for rapid roll‑out across Africa. It's an inflection point in global health and malaria control. Critical treatment gap addressed Malaria remains one of the most devastating diseases in sub‑Saharan Africa, with nearly 263 million cases and roughly 600,000 deaths in 2023. Shockingly, infants under five account for three‑quarters of these deaths. Until now, infants weighing less than 4.5 kg – roughly 10 lb – had no approved therapy. They were administered antimalarial tablets formulated for older children, a practice fraught with dosing errors and toxicity risks. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 5 Books Warren Buffett Wants You to Read In 2025 Blinkist: Warren Buffett's Reading List Undo Coartem Baby fills this critical void, offering a dosage specifically tailored to newborn metabolism and weight. Infant-centric design and administration This pediatric formulation includes artemether-lumefantrine, the proven gold-standard antimalarial adopted globally since 1999. Coartem Baby is not just the first of its kind – it's built for infants' realities. It's the new infant‑friendly features that matter most: Sweet cherry-flavored, dispersible tablet that dissolves in water or breast milk, making it easy and palatable to administer in low-resource settings. Optimized dosing based on metabolic differences in neonates: the lower dose ratio (artemether-lumefantrine) addresses immature liver function (low dose for infants 2–5 kg). Clean and safe delivery ensures compliance – no crushed pills or makeshift dosing methods. These characteristics simplify administration in low‑resource settings, proving much more effective than crushed or adapted pediatric tablets, especially for caregivers who face limited infrastructure and training. Backed by clinical evidence The drug's effectiveness is rooted in strong Phase II/III clinical trials, collectively known as CALINA, conducted across multiple African countries, including Burkina Faso, Kenya, Nigeria, Mali, Zambia, the DRC, and more. These trials confirmed dosing safety and efficacy in infants under 5 kg, accounting for their unique pharmacokinetics due to immature liver function. As Professor Umberto D'Alessandro from the London School of Hygiene & Tropical Medicine explains, infants metabolize drugs differently, making tailored formulations essential. A fast‑track global roll‑out Swissmedic's approval, granted under its Marketing Authorization for Global Health Products scheme, also engages eight malaria-endemic African countries – Burkina Faso, Côte d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda. These nations can now fast‑track local approval within 90 days, paving the way for widespread pediatric access. Access and equity: The 'Not‑for‑profit' ethos Novartis, with the support of Medicines for Malaria Venture (MMV), plans to distribute Coartem Baby largely on a not-for-profit basis, aligning with its long-standing commitment, having provided over 1.1 billion malaria treatments since 1999. Co-funded by health agencies like EDCTP and SIDA, and built in partnership with PAMAfrica, the rollout is structured to democratize access across Africa. The broader context This release comes amid alarming trends: reductions in malaria aid funding, expanding mosquito ranges due to climate change, and rising drug resistance. While vaccines like RTS,S are only approved for older infants (≈5+ months), Coartem Baby fills a critical early-life gap. As Dr. Bhargavi Rao from LSHTM notes, 'Even very low levels of parasites can give…severe malaria and death' in neonates. Looking ahead The approval of Coartem Baby is more than a pharmaceutical milestone – it is a public‑health triumph. By delivering a scientifically crafted solution for the tiniest malaria patients, Novartis and MMV are not only saving lives but also redefining equitable healthcare delivery. However, some challenges remain. Ensuring transparent pricing, resilient supply chains, and community education is paramount. Continued monitoring of drug resistance and scale-up of complementary tools – like insecticide‑treated nets and vaccines – will be critical. Encouragingly, Novartis continues to invest in cutting‑edge antimalarials (e.g., ganaplacide) and downstream pediatric formulations. USFDA allows emergency use of drug for coronavirus
Time of India
09-07-2025
- Health
- Time of India
The first drug to treat infants sick with malaria is approved by Swiss authority
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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo The newly approved medication, Coartem Baby , is a combination of two antimalarials. 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. Live Events 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.
