Latest news with #MMV
Fast Company
08-07-2025
- Health
- Fast Company
Finally: A malaria drug made just for babies has been approved – here's why it matters
The first ever treatment for malaria in young babies and infants has been approved. On Tuesday, Novartis announced it had received approval for the treatment, Coartem Baby (known as Riamet Baby in some countries) in Switzerland. Eight African countries, who participated in the assessment, are also expected to quickly approve the treatment. Novartis worked in collaboration with the Medicines for Malaria Venture (MMV), a Swiss-based nonprofit which works to prevent and develop treatments for the mosquito-borne disease, on the drug. Until now, malaria treatments have only been tested in children at least six months old and no drug had not been an approved malaria treatment for infants under 9.9 pounds (4.5 kilograms). And, because there had been no drug designed specifically for babies and small children, treatment has involved the very young taking treatments designed for more developed bodies. It also led to what Novatis called a 'treatment gap' for the age group. 'Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,' said Novartis CEO Vas Narasimhan in a press release. Narasimham continued, '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. Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.' According to Novartis, infection rates in Africa range from 3.4% and 18.4% in infants younger than six months old. In 2023, malaria caused around 597,000 deaths, most of which were in Africa, per The World Health Organization. Three quarters (76%) of those deaths were in children under the age of five. Martin Fitchet, CEO of MMV said in the press release, 'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated.' Fitchet continued, 'The approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.' In recent years, malaria vaccine development has been accelerated. Still, there have been significant financial, logistical, and social hurdles, in deployment to the most vulnerable. However, Novartis says it plans to introduce its drug on a largely not-for-profit basis in order to help hard-hit 'endemic' areas fight the illness.
Yahoo
08-07-2025
- Health
- Yahoo
Swissmedic approves Novartis' malaria medicine for babies
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Novartis' Coartem (artemether-lumefantrine) Baby, described as the first malaria medicine for newborns and young infants. Known as Riamet Baby in some regions, the new treatment is set to address a critical gap in malaria care for this vulnerable age group. The approval opens the door for eight African countries to expedite their approval processes, leveraging the Marketing Authorization for Global Health Products procedure. Novartis is preparing to introduce the treatment, primarily on a not-for-profit basis, to improve access in malaria-endemic regions. Novartis CEO Vas Narasimhan stated: '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. 'Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.' Developed in partnership with Medicines for Malaria Venture (MMV) and as part of the PAMAfrica consortium, the medicine has been designed to be dissolvable, even in breast milk, and has a sweet cherry flavour. This innovation simplifies administration for the youngest patients. Infants weighing under 4.5kg previously had no approved malaria treatment and were at risk of overdose and toxicity due to the use of older children's formulations. The Swissmedic approval is based on results from the Phase II/III CALINA study, which explored a new ratio and dose of Coartem to suit the metabolic needs of babies weighing below 5kg. The treatment is now indicated for infants and neonates between 2kg and less than 5kg, targeting acute, uncomplicated infections caused by Plasmodium falciparum or mixed infections that include P. falciparum. Novartis recently completed its acquisition of US-based biopharmaceutical company Regulus Therapeutics for $1.7bn, strengthening its renal disease portfolio. "Swissmedic approves Novartis' malaria medicine for babies" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Indian Express
08-07-2025
- Health
- Indian Express
First-ever malaria treatment for babies approved, rollout expected in Africa soon
In a major milestone, Swiss authorities have approved Coartem Baby, the first-ever malaria treatment specifically designed for babies and very young children. Developed by pharmaceutical company Novartis, the new formulation is reportedly set to be rolled out in African nations within weeks, particularly in countries with the highest malaria burden. Until now, no malaria treatments had been officially approved for infants weighing less than 4.5 kg. Instead, babies were given formulations designed for older children, which carried the risk of overdose due to differences in how infants' bodies process medicine. According to data from 2023, cited by the BBC, malaria was responsible for approximately 597,000 deaths, with the overwhelming majority occurring in Africa. Nearly 75 per cent of these deaths were children under the age of five. Despite existing treatments for older children, this newly approved formulation is the first to address the youngest and most vulnerable patients. Experts have long warned of a 'treatment gap' due to the lack of safe, approved options for infants. This gap is now expected to be addressed with the launch of Coartem Baby, also known as Riamet Baby in some countries. The treatment was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Swiss-based non-profit supported by the governments of Britain, Switzerland, the Netherlands, the World Bank, and the Rockefeller Foundation. The formulation is designed to dissolve easily, including in breast milk, and according to a Reuters report, has a sweet cherry flavour to ease administration. Eight African countries—Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—participated in the assessment and clinical trials of Coartem Baby. These countries are expected to be the first to approve and adopt the treatment. Novartis plans to distribute the drug on a largely not-for-profit basis. CEO Vas Narasimhan described the approval as a pivotal moment in the global fight against malaria. '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. Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,' the BBC quoted him as saying. The BBC report also quoted MMV CEO Martin Fitchet who said, 'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated. The approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.' Novartis originally launched Coartem in 1999. The new formulation represents a crucial step in making malaria treatment more accessible to an often-overlooked population—infants at the highest risk of severe disease and death.
BBC News
08-07-2025
- Health
- BBC News
Wetin to know about di first malaria medicine for babies wey don dey approved for use
Di first malaria treatment wey dey suitable for babies and very young children don dey approved for use. Di drug, wey dey known as Coartem Baby or Riamet Baby for some countries, bin dey developed by Novartis in collaboration with di Medicines for Malaria Venture (MMV), wey be a Swiss-based not-for-profit organisation wey bin first get backing from di British, Swiss and Dutch Governments, as well as di World Bank and di Rockefeller Foundation. E dey expected for roll out for African countries in weeks. Until now, no approved malaria drugs dey specifically for babies. Instead, dem dey treat dem with di ones wey dey formulated for older children wey involve a risk of overdose. Half a million deaths for 2023 For 2023 - di year wey di most recent figures dey available - malaria bin dey linked to around 597,000 deaths. Almost all of di deaths bin dey for Africa, and around three quarters of dem na children under five years old. Malaria treatments for children dey, but until now, no one dey specifically for di very youngest babies and small children, wey weigh less dan 4.5kg or around 10lb. Instead, dem dey treat dem with drugs wey dey designed for older children. But e involve risks, as doses for dis older children fit no dey safe for babies, wey dia liver functions still dey develop and dia body dey process medicine differently. Experts say dis don lead to wetin dey described as a "treatment gap". Now, dis new medicine, developed by di drug company Novartis, don dey approved by di Swiss authorities and e dey likely to dey rolled out in regions and countries with di highest rates of malaria within weeks. Novartis dey plan to introduce am on a largely not-for-profit basis. Di smallest and most vulnerable Di company chief executive, Vas Narasimhan, say dis na important moment. "For more dan three decades, we don dey chook eye in di fight against malaria, working relentlessly to deliver scientific breakthroughs wia dem dey needed most. "Togeda with our partners, we dey proud to done go further to develop di first clinically proven malaria treatment for newborns and young babies, ensuring say even di smallest and most vulnerable fit finally receive di care dem deserve." Eight African nations also take part in di assessment and trials of di drug and dem dey expected to be among di first to access am. Martin Fitchet, CEO of MMV, say, dis na important step on di road towards ending di ogbonge palava of malaria. "Malaria na one of di world deadliest diseases, particularly among children. But wit di right resources and focus, E fit dey eliminated. "Di approval of Coartem Baby provide a necessary medicine wit optimised dose to treat a neglected group of patients and offer a valuable addition to di antimalarial toolbox." Dr Marvelle Brown, associate professor for di University of Hertfordshire School of Health, Medicine and Life Sciences, say dis suppose dey seen as a major breakthrough in saving di lives of babies and young children. "Di death rate for malarial infections, particularly for sub-Saharan Africa dey very high - over 76% of deaths dey hapun in children under five years old. "Increase in death from malaria dey further increased in babies born with sickle cell disease, primarily due to a weak immune system. "From a public health perspective, Novartis making dis not-for-profit fit help wit reducing inequality in access to healthcare."
Yahoo
08-07-2025
- Health
- Yahoo
Novartis receives approval for first malaria medicine for newborn babies and young infants
Coartem® (artemether-lumefantrine) Baby becomes first malaria treatment approved for newborn babies and young infants Rapid approvals in eight African countries now expected under a special global health scheme run by Swiss agency for therapeutic products (Swissmedic) Novartis plans to introduce infant-friendly Coartem Baby on largely not-for-profit basis to increase access in areas where malaria is endemic Basel, July 8, 2025 – Novartis today announced Coartem® (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants. The new treatment, also known as Riamet® Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) to treat the potentially deadly mosquito-borne disease. Eight African countries also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency's Marketing Authorization for Global Health Products procedure.1 Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic. '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,' said Vas Narasimhan, CEO of Novartis. 'Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.' Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap. They have instead been treated with formulations intended for use in older children, which may increase the risk of overdose and toxicity. Malaria vaccines are also not approved for the youngest babies.2 Some 30 million babies are born in areas of malaria risk in Africa every year,3 with one large survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than 6 months old.4 However, current data on malaria in young babies is extremely limited as they are rarely included in clinical trials of antimalarial agents.5,6 'The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials,' said Professor Umberto D'Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. 'That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.' The new dose strength designed for young infants was developed by Novartis with the scientific and financial support of MMV, and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer. '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, CEO 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.' About the CALINA studyThe Swissmedic approval is based on the Phase II/III CALINA study, which investigated a new ratio and dose of Coartem (artemether-lumefantrine) to account for metabolic differences in babies under 5 kilograms. It is indicated for the treatment of infants and neonates weighing between 2 and less than 5 kilograms with acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum. Coartem is known by the brand name Riamet in Switzerland and some other countries. About malariaMalaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.7 About Novartis in malaria innovationNovartis finds breakthroughs for diseases neglected by science and brings innovative medicines to communities on the margins of healthcare, building on 85 years of innovation in global health. Novartis has built the industry's largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases, backed by nearly USD 490 million in funding for global health R&D since 2021. This includes four new antimalarial compounds with the potential to combat rising drug resistance, one of which is just completing Phase III trials, and another which is a potential single-dose cure. Since 1999, Novartis has delivered more than 1.1 billion treatment courses of antimalarials, mostly at no profit, including 500 million treatments of a child-friendly formulation for babies weighing at least 5 kilograms. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. About MMVMMV is a Swiss not-for-profit working to deliver a portfolio of accessible medicines with the power to treat, prevent and eliminate malaria. Born in 1999 to drive health equity, MMV closes critical gaps in research, development and access – to expand the use of existing antimalarials and innovate new compounds. This starts with women and children. As of 2024, MMV-supported products have effectively treated more than 711 million patients. For more information, visit Follow MMV on social media: X, LinkedIn, YouTube and Facebook References Eight African countries participated in Swissmedic's Marketing Authorization for Global Health Products (MAGHP) procedure for Coartem Baby – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda -- and are expected to approve the medicine following approval by Swissmedic. These eight countries account for 47% of estimated cases in 2023, according to the WHO's Global Health Observatory WHO. Malaria vaccines (RTS,S and R21) Reddy, Valentina et al. Global estimates of the number of pregnancies at risk of malaria from 2007 to 2020: a demographic study. The Lancet Global Health, Volume 11, Issue 1, e40 - e47 Ceesay SJ et al. Malaria Prevalence among Young Infants in Different Transmission Settings, Africa. Emerg Infect Dis. 2015 Jul;21(7):1114-21. doi: 10.3201/eid2107.142036. PMID: 26079062; PMCID: PMC4480393. D'Alessandro U, et al. Malaria in infants aged less than six months - is it an area of unmet medical need? Malar J. 2012 Dec 2;11:400. doi: 10.1186/1475-2875-11-400. PMID: 23198986; PMCID: PMC3529680. Dobbs, et al. Plasmodium malaria and antimalarial antibodies in the first year of life. Parasitology. 2016;143(2):129-138. doi:10.1017/S0031182015001626 WHO. Malaria. # # # Novartis Media RelationsE-mail: Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
