Novartis medicine becomes the first malaria therapy for newborns and babies
Regarding medical products for malaria, neonates are underserved. Medicines and vaccines available to adults and older children are not approved by babies – these dosages are too strong to be used safely in such young people. The current regulatory decision brings new Novartis combination drugs to infants, making it the first approved malaria treatment for this vulnerable patient group.
Novartis announced Tuesday that Switzerland’s drug regulator, Swiss drug regulator, has approved the drug for use in newborns and young babies. The regulatory assessment includes participation from eight African countries that are now expected to follow their recognition of the drug. Baselnova, Switzerland-based, said it plans to introduce Coarem nonprofit in areas endemic to malaria.
CoArtem combines two antimalarial drugs, Artemether and Lumefantrine, each bringing different mechanisms of action. Artemether works quickly to lower levels of the Plasmodium that drives malaria. This property of Artemether comes from a factory called Sweet Wormwood, which was originally determined by Chinese researchers. Lumefantrine has a longer effect, eliminating parasites that remain after Artemether has completed its work. Pairing of the two compounds reduces the risk of drug resistance to using either drug alone.
In the mid-1990s, Novartis worked with Chinese scientists to develop a combination of malaria drugs that would become homosexual. Swissmedic approved the drug in 1999; 10 years later, the FDA signed it. But this formula is a tablet tested in adults and children. In a statement included in the Novartis approval announcement, Professor Umberto D’Alessandro, director of the Gambia MRC division at the London School of Hygiene and Tropical Medicine, said children at least six months old had tested available malaria treatments in children only, keeping babies shut up in clinical trials.
“This is important because newborns and babies have immature liver function and metabolize some medications in different ways, so the dosage of larger children may not be suitable for small babies,” he said.
Novartis has partnered with the Swiss nonprofit Malaria Risk Organization (MMV) to develop a new dose and formula for young babies. The infant formula is called Coartem Infants, considers the metabolic differences in infants weighing less than 5 kg (less than 10 lbs). This formula dissolves in liquids including breast milk and has a sweet cherry flavor, making it easier to apply.
Swissmedic’s regulatory decision is based on the results of a Novartis-sponsored Phase 2/3 study conducted in Burkina Faso, the Democratic Republic of the Congo, Kenya, Kenya, Mali, Nigeria and Zambia. Last year, MMV and Novartis announced that the drug met its goal of assessing safety and efficacy. These results were submitted to regulatory review. The course of Swiss drug covers the use of antibacterial products in infants with 2 to 5 kg, acute, non-complex infections caused by Plasmodium falciparum or a mixed infection including the parasite. In some countries, including Switzerland, the product is known for its Riamet brand.
Coartem was previously housed under Sandoz, a former Novartis generic and biosimilar pharmacist. In 2023, Sandoz started from Novartis and became an independent, publicly traded company. Related to derivatives, transferring colleagues’ assets to Novartis, the drug is comparable to the pipeline of product candidates for malaria and neglected tropical diseases.
Lumefantrine is being tested with another compound called Ganaplacide, which has the potential to provide another combination method for simple malaria. According to Novartis’ annual report, the program has reached 3-phase testing. Cipargamin is a PFATP4 inhibitor that is being evaluated for simple and severe malaria in a separate phase 2 test. Novartis said it has invested nearly $490 million in global health research and development since 2021.
Photos: drpnncpp, Getty Images
