Finally: A malaria drug made just for babies has been approved – here's why it matters
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
Eluciderm, Inc. Announces U.S. FDA Clearance of IND Application for ELU42
SAN DIEGO--(BUSINESS WIRE)--Eluciderm, Inc., a clinical-stage pharmaceutical company developing small molecule therapeutics designed to promote healing and regenerative repair of injured tissue, announced today that on June 30, 2025 the company received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND), ELU42, for a Phase 1/2a open-label study evaluating safety and efficacy in patients with diabetic foot ulcers (DFUs). ELU42 is a novel, topical, small molecule Wnt modulator with bacteriostatic properties for the treatment of chronic open wounds. 'The FDA's IND clearance of ELU42 marks an exciting transition for Eluciderm from preclinical research to full clinical-stage company,' said Daniel D. Holsworth, PhD, Chief Executive Officer of Eluciderm. Share 'The FDA's IND clearance of ELU42 marks an exciting transition for Eluciderm from preclinical research to full clinical-stage company,' said Daniel D. Holsworth, PhD, Chief Executive Officer of Eluciderm. 'ELU42 is the first in our pipeline of Wnt signaling modulators developed around a novel mechanistic approach to tissue healing and repair that we believe will shift the paradigm from simply managing patients' wounds to truly healing them.' The ELU42 Phase 1/2a trial is an open-label study evaluating the topical spray for safety and efficacy in a cohort of 15 patients with diabetic foot ulcers (DFUs). The study is set to begin the first week of August 2025 at three U.S. sites and will assess multiple clinical endpoints, including wound area reduction, closure rates, and safety metrics. The data from this trial will establish the foundation of a Phase 2 clinical trial in 2026, with strong potential for a Breakthrough Therapy designation in early 2027. 'This first-in-human trial is a defining moment for Eluciderm. ELU42 has the potential to change the standard of care for patients worldwide who suffer from non-healing wounds and underscores our commitment to transforming wound care,' said John P. Delgado, MD, Chief Medical Officer of Eluciderm. 'We believe everyone can be a SuperHealer TM.' About Eluciderm, Inc. Eluciderm is a San Diego-based clinical-stage pharmaceutical company pioneering topical small-molecule therapies that awaken the body's innate healing capacity. The company's approach is grounded in a targeted mechanism of action that selectively modulates the Wnt signaling pathway, with the goal of redefining wound healing and clinical outcomes. Eluciderm's platform, anchored by ELU42, includes therapeutics designed to promote healing and regenerative repair of a wide variety of wound injuries, including those from third-degree burns, surgical incisions, elastic cartilage reconstructions, pulmonary fibrotic damage from environmental factors, and inflammatory skin diseases. Based on favorable data from the National Cancer Institute's NCI-60 screening program, Eluciderm is also in the early stages of investigating oncological applications of their mechanistic methodology. For more information, visit and follow Eluciderm on LinkedIn. Forward-Looking Statements This press release may contain 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the initiation, timing, and progress of clinical trials; the potential therapeutic benefits of ELU42; and the development plans for Eluciderm, Inc.'s pipeline. These forward-looking statements are based on current expectations and beliefs and are subject to a number of risks and uncertainties, including those related to clinical development, regulatory approvals, manufacturing, and commercialization. Actual results may differ materially from those expressed or implied in the forward-looking statements. Eluciderm, Inc. disclaims any obligation to update these statements except as required by law.
Yahoo
an hour ago
- Yahoo
Scientists raise red flags after US lake sets shocking world record: 'We are worried'
Late in 2024, scientists announced they had discovered world-record levels of toxic "forever chemicals" in a New Mexico lake. Their newest study confirmed the results and analyzed the factors that contributed to this contamination. The research expanded on the first study to examine PFAS contamination in the waters of Holloman Lake along with soils, plants, algae, fish, reptiles, and various species of birds and mammals, according to a summary from the University of New Mexico published by All the samples had very high PFAS concentrations, up to or exceeding 10,000 times what the Environmental Protection Agency recommends in its drinking water standards. Lake waters showed the highest concentration of PFAS anywhere in the world to date, as did one plant composite sample. The team also discovered the highest PFAS concentration recorded in a bird to date. The scientists found that the contamination extends beyond the lake itself, and they linked this to past flooding events. For instance, the most contaminated soil sample was located downstream from the lake. In the past, water from the lake sometimes flowed past a dam and into a network of playas — "shallow, generally circular, depressions with clay-lined basins" that "form at the lowest point in an enclosed watershed" and often serve as temporary lakes, according to the university. The scientists don't know how contaminated the playas in the area might be but stated that they can serve as important habitats for migratory birds. Per- and polyfluoroalkyl substances have been linked to a number of health concerns, including decreased fertility, increased risk of cancer, and reduced ability of the body's immune system to fight infections. The scientists are worried that migratory birds will become heavily contaminated at Holloman Lake and then move on to other areas, putting hunters and people elsewhere at risk. They also recorded a herd of oryx — a nonnative African big-game species that was released in the region from 1969 and 1977 — visiting the lake to drink and are worried that hunters could ingest contaminated meat. Do you worry about having toxic forever chemicals in your home? Majorly Sometimes Not really I don't know enough about them Click your choice to see results and speak your mind. The Santa Fe New Mexican added that consuming just one bite of meat from a Holloman Lake duck would expose someone to more PFAS than is recommended for a lifetime. "We are worried about the possibility of toxicity on reproduction and development in local birds, some of them sensitive species like the snowy plover," study lead author Jean-Luc Cartron said. "Contamination by PFAS could also be transgenerational, with contamination affecting not just animals living at or visiting Holloman Lake but also future generations." Though Holloman is the most PFAS-laden lake discovered so far, there are a number of other large water bodies contaminated with these chemicals. For instance, one study found forever chemicals all over the Great Lakes Basin, including in air, rain, and water. In January, the New Mexico Department of Health issued an advisory for anyone who has eaten or captured wildlife from Holloman Lake in the past decade, urging them to speak to their medical provider. Hunting has been prohibited there since 2024. And though PFAS are known for being difficult to remove from the environment, scientists have made breakthroughs, which could help safeguard people and wildlife in the future. For instance, researchers at the University of Illinois found a way to remove the full spectrum of PFAS from water in a single process, and a team at the University of Rochester is doing similar work. Join our free newsletter for good news and useful tips, and don't miss this cool list of easy ways to help yourself while helping the planet.
Yahoo
2 hours ago
- Yahoo
The $20 Million Bet on CRISPR to Cure Rare Childhood Diseases
Jennifer Doudna, Priscilla Chan Zuckerberg Credit - David Paul Morris—Bloomberg/Getty Images; Suzanne Cordeiro—AFP/Getty Images Rare genetic diseases are challenging for patients and their families—made all the more overwhelming because symptoms tend to appear soon after birth. To date, there haven't been many reliable treatment options for these babies. The few that do exist involve invasive and risky procedures that don't often have a high rate of success. But there is a new source of hope for many of these families: the Center for Pediatric CRISPR Cures at the University of California San Francisco. The center—plans for which were announced July 8—is a collaboration between Jennifer Doudna, director of the Innovative Genomics Institute at the University of California, Berkeley who also earned the Nobel Prize for her work in co-discovering the gene-editing technique CRISPR, and Dr. Priscilla Chan, co-CEO and co-founder of the Chan Zuckerberg Initiative. Supported by $20 million from the Chan Zuckerberg Initiative, the center focuses on treating rare genetic diseases in children, starting with a group of eight kids who will enroll in a clinical trial to access a CRISPR therapy designed specifically for them. Doctors and researchers, including Chan and Doudna, believe that CRISPR can be used to change and correct a range of genetic mutations and scaled up to help more patients. And the medical teams plan to start enrolling patients immediately. "We want to ensure that CRISPR-based therapies become widely available, especially for rare diseases that likely won't be the target for pharmaceutical companies," Doudna tells TIME. Read More: The 4 Words That Drive Your Doctor Up the Wall The partnership was inspired by the recent success in treating KJ Muldoon, the first baby to receive a customized CRISPR treatment. KJ was born at the Children's Hospital of Philadelphia with a rare genetic disease that prevents him from breaking down proteins properly. The therapy, called base-editing, replaced a faulty letter in KJ's DNA with the correct one that now lets him eat some protein. KJ's treatment represents the next phase of CRISPR-based therapies. While CRISPR treatments have been approved by the FDA to treat sickle cell disease and certain types of beta thalassemia, those therapies involve removing cells from patients, editing them with CRISPR to correct the genetic defect, and then infusing those cells back to the patients. In KJ's case, the CRISPR editing occurred in his own body, via three injections of a therapy developed just for him. That's the same model that the new center will use. 'With that story, there was a lot of momentum within our teams about whether we could do that again, and how we could learn from this to create a pipeline to reduce cost and make this therapy much more widely available,' Doudna says. Doudna thought of Chan, whose initiative has the mission of curing, preventing, or treating all diseases by the end of the century. It was an ideal match, since Chan had trained as a pediatrician at the University of California San Francisco and spent eight years treating children with rare genetic diseases after finishing medical school. 'When Jennifer called me, I thought, 'This is perfect,'' Chan tells TIME. She recalls encountering families whose babies were affected by diseases so rare that there was often little, if any, information about them. 'I have seared in my mind the image of a parent handing me a PDF that they carried around to explain to each resident that this is what we have, and this is all that we know about it. I carry that around daily.' The experience inspired her to create the Rare As One program at the Chan Zuckerberg Initiative, a network of patients, researchers, and scientists from different disciplines that highlights the need for basic research needed to better understand these conditions in order to develop more effective treatments for them. Read More: The Surprising Reason Rural Hospitals Are Closing CRISPR, with its ability to target specific genetic mutations, holds the most promise for changing the course of such diseases. But time is of the essence. In KJ's case, the entire process of identifying his mutation, developing the treatment, testing it, and receiving FDA clearance took nine months. KJ was just six months old when he received his first CRISPR treatment. Acting that quickly is critical for conditions like these, since once cells or organs are damaged by disease-causing mutations, they can't always be rescued. The idea is to intervene with a CRISPR therapy to minimize the effects that the mutations could have. Currently, about 6,000 rare diseases affect 300 million people worldwide, and 72% of them are linked to genetic aberrations. A similar proportion primarily affect children. The new center will focus on identifying disease-causing mutations that can easily be targeted—such as in the liver, as in KJ's case. 'Jennifer and her team, and the team at UCSF, will be very careful in choosing mutations that are amenable to this treatment,' says Chan. 'Not all mutations will work well with this version of there will be a delicate balance in choosing patients who stand to benefit the most in this situation.' Patients will join a clinical trial to receive the treatment, and the research team will study them to learn from their experiences and continue to improve the treatment and the process. Read More: Why It's So Hard to Have Your Fertility Tested In the first cases that the center will try to treat, the FDA will consider each treatment on its own and decide whether to approve the customized therapy for that particular patient. But, says Doudna, 'as we continue to get more information on the safety and potential risks of CRISPR for different indications, what is emerging is the potential to designate CRISPR as a platform technology.' That means that if regulators approve the framework of the CRISPR gene-editing process, doctors would not need to conduct animal tests for each new CRISPR therapy designed for a patient. The only thing that would change would be the guide RNA, Doudna says, which carries the genetic instructions for finding the specific mutation that needs to be addressed. 'Even there, most of the guide RNA stays the same, and it's just the piece at the end providing the molecular zip code that changes.' Key to making that happen will be advances in other scientific areas, including using AI to predict how changing specific genes will affect a cell's function and what potential health outcomes a CRISPR-based treatment might have. That work is ongoing separately at places like Chan Zuckerberg Initiative and elsewhere, says Chan. Eventually, says Doudna, 'we hope as the process moves forward, it will be possible to both predict clinical outcomes of CRISPR therapies accurately and ensure that by changing just a little part of the guide RNA, everything else will remain the same, so you don't have to do full-blown animal testing for every single iteration of CRISPR. If that becomes possible, then it will make CRISPR a lot cheaper and a lot faster to test these kinds of therapies.' That would make it available for many more patients as well. Contact us at letters@
