Swiss medicines authority issues first approval for antimalarial drug for treatment of infants

GENEVA AP Switzerland s healthcare products authority has granted the first approval for a malaria medicine designed for small infants touted as an advance against a condition 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 recovery of babies with body weights between and kilograms nearly to pounds which could pave the way for hard-hit African nations to follow suit in coming months The agency announced that the decision is considerable in part because it s only the third time it has approved a therapy under a fast-track authorization process in coordination with the World Vitality Organization to help emerging countries access needed healing The newly approved medication Coartem Baby is a combination of two antivirals 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 mentioned the burden of malaria in very young children is relatively low compared to older kids But access to such medicines is essential to all he noted There is no doubt that any child of whichever age and particularly very very young ones or very light-weighted ones require a cure revealed Bassat the director- general of the Barcelona Institute for Global Strength known as ISGlobal Up to now antimalarial drugs designed for older children have been administered to small infants in careful tactics to avoid overdose or toxicity in what Bassat called a suboptimal approach 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 disclosed Ruairidh Villar a Novartis spokesperson declared that eight African countries took part in the assessment and are expected to approve the medicine within days The company explained 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 noted access strategies for the new medicine must include a look at where demands are greatest and urged clarity on pricing We need transparency around what Novartis largely not for profit report means including publicly available pricing which countries will benefit and how long for she wrote in an email Still she reported it was vital to completely have a suitable and safe medication for very young children more than years since WHO first pre-qualified Coartem for older age groups She noted the announcement comes as resistance to antimalarials has been growing and a great number of traditional donor countries have been sharply cutting outlays for global physical condition including for malaria services and research The mosquito-borne illness is the deadliest disorder in Africa whose billion people accounted for of an estimated malaria deaths worldwide in according to WHO More than three-quarters of those deaths were among children Source