Novartis wins approval: First malaria treatment drug for newborns and babies is here
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
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
an hour ago
- Time of India
4 diet mistakes that can worsen fatty liver, even if oil and sugar intake is moderate
With non-alcoholic fatty liver disease (NAFLD) cases rising, dietary choices are crucial. Excessive salt intake, often overlooked, can worsen the condition. Processed foods, including seemingly harmless items like white bread, also contribute to liver damage. Red meat and processed meats should be avoided, while adequate protein intake is essential for proper liver function and fat removal, according to recent studies. Fatty liver disease is becoming more common than ever. About 32% of the adults have non-alcoholic fatty liver disease (NAFLD), according to a recent study . Lifestyle factors play a key role in the rising number of cases. Among them is diet. People living with NAFLD often limit oil and sugar intake. While taking off or limiting these ingredients from the diet can help, that's not enough. Here are four mistakes people make when it comes to their diet that worsen fatty liver. Excessive salt consumption While most people consciously avoid added sugars, one ingredient that is overlooked is salt. Excessive sodium in the diet can increase the risk of NAFLD. Eating food loaded with salt may lead to insulin resistance, high blood pressure, and oxidative stress, all of which may contribute to the accumulation of fat in the liver. People with NAFLD or any liver ailments should limit sodium intake to less than 2,300 milligrams per day. Those with hypertension should cut back on salt. The intake should not be more than 1,500 mg per day. Eating processed foods Even if you are on a balanced and nutritious diet, sneaking processed foods in between may contribute to liver disease and worsening of the already existing conditions. Processed food is not just about chips and biscuits; even white bread and pasta count. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 15 most beautiful women in the world Undo White flour is often highly processed, and such foods raise your blood sugar more than whole grains, as they lack fiber. Processed foods are also loaded with oil, salt, sugar, and preservatives, which wreak havoc on health. Red meat consumption (Pic courtesy: iStock) People with fatty liver should avoid red meat at all costs. Studies have consistently shown that red meat consumption may worsen NAFLD. A 2022 study found that people who consumed red meat were at increased odds of NAFLD. The study also showed an association between organ meat consumption and NAFLD. Along with red meat, one should also avoid eating processed meats. Processed meats are high in both sodium and saturated fat, all of which contribute to fatty liver disease. These include bacon, hot dogs, deli meats like salami and pepperoni, and canned meats. Not eating enough protein (Pic courtesy: iStock) This may be surprising, but not getting adequate amounts of protein can lead to fat buildup. A deficiency in protein may affect the liver's ability to process and remove fats. A 2020 study found that a high-protein, calorie-reduced diet can cause the harmful liver fat to melt away more effectively than a low-protein diet. Focus on sticking to a low-calorie diet that is rich in high-quality protein such as lean meats, fish, eggs, or legumes. Keep your heart young post-30s with these 4 simple ways
Time of India
an hour ago
- Time of India
Sr ophthalmologist Dr P Namperumalsamy no more
Madurai: Dr P Namperumalsamy, chairman-emeritus of Aravind Eye Hospital, who transformed eye care in Tamil Nadu and beyond, died on Thursday at the age of 85. Known for his medical excellence and deep sense of service to society, he was guided lifelong by the principle that none should remain blind simply because they are poor. He is survived by his wife Dr G Natchiar, director-emeritus of the hospital, and sons Venkatesh Prajna and Vishnu Prasad. "My father was thorough professional and a perfectionist, be it at work or home. He performed his duties diligently as a father, as a grandfather, and a great grandfather as well,'' Prajna told TOI. "The way he challenged himself constantly and aspired for global standards despite coming from a humble background is a rare feat," he said. Born on July 9, 1940 in Ambasamudram village in Theni district, Namperumalsamy did his MBBS at Madurai Medical College. His classmate, Dr Annamalaisamy, 86, a cardiologist, recalls that Dr Nam, as he is fondly referred to, entered the college as a timid boy but grew soon to be the smartest. "I met him only two months ago. He never forgot his roots. Even now, after retiring, he has taken an interest in agriculture," he said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like American Investor Warren Buffett Recommends: 5 Books For Turning Your Life Around Blinkist: Warren Buffett's Reading List Undo Namperumalsamy started his career at Government Rajaji Hospital and established India's first Low Vision Aid Clinic in 1967. After training in the US, he started the Vitreous Surgery Centre at GRH, a first of its kind in India, and then Retina Vitreous Clinic at Aravind Eye Hospital in 1979. Dr Sridhar, state president elect, IMA, Tamil Nadu, says Namperumalsamy was the perfect definition of a gentleman. Under his stewardship, Aravind became a global model for efficient, high-volume, high quality eye care, winning the Conrad N. Hilton Humanitarian Prize in 2010. TIME magazine recognized him among its 100 most influential people in 2010 for transforming cataract surgery into a rapid, assembly-line operation. He was also a recipient of Padma Shri. Several political leaders including chief minister M K Stalin condoled his death. "He gave vision to lakhs of people,'' Stalin said. Dr Namperumal's mortal remains were kept at their house in Anna Nagar in Madurai on Thursday, and will be cremated in his native village on Friday.
Time of India
an hour ago
- Time of India
Ambulance delay due to traffic stalls emergency care
Thane: Traffic congestion on Thane highways isn't just a daily hassle for motorists—it's a critical challenge for doctors and hospitals as ambulances ferrying patients in critical condition often have to struggle through narrow, clogged routes, delaying emergency care. "Our field staff frequently comes across ambulances stuck in traffic, especially on the highways. While motorists also cooperate, we have instructed our staff to immediately prioritise and clear the path for these vehicles," said Pankaj Shirsat, deputy commissioner, Thane Traffic. Activists also point out how social media is often flooded with alerts about ambulances stuck in jams. Doctors say precious time is often lost in transporting patients—particularly road and rail accident victims — to hospitals, in addition to the time required to analyse the patient's health before admission. "Critically injured patients often deteriorate before reaching the facility," said a railway police escort officer. You Can Also Check: Mumbai AQI | Weather in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai While the Thane Municipal Corporation (TMC) planned a bike ambulance service for faster first-aid response in congested areas, it remains non-operational. Spotting the gap, a private hospital in Thane recently launched an AI-integrated 5G Smart Ambulance. "This ambulance transmits live patient data — ECG, blood pressure, oxygen saturation—to the emergency room en route," said Dr Ankit Biyani, HOD of Emergency Medicine at KIMS Hospitals, which launched the service. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Global MBA for executives. Study online. IIMK UWA Undo "AI continuously analyses vitals, allowing our doctors to start treatment protocols before arrival." The system aims to cut down emergency room processing time. "In trauma, cardiac arrest, or stroke, the golden hour can mean life or death," added Dr Amit Raodeo, Chief of Critical Care. City-based Dr Mahesh Bedekar emphasised the need to scale such services. "With govt support, these innovations can be expanded." to benefit more people.
