First malaria drug for newborns, young infants gets approval

First malaria drug for newborns, young infants gets approval
 

What you need to know:

  • According to information from the Ministry, around 16 malaria deaths are reported in Uganda daily, with 10 happening in children under five.
  • The government has recently launched a malaria vaccine for children, but this is not available for children under six months.

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A malaria drug, Coartem Baby, which was recently assessed in Uganda and other African countries, has been approved as the first appropriate treatment for the deadly infection in newborns and young infants.

This was announced yesterday by the Medicines for Malaria Venture (MMV), a Swiss-based not-for-profit organisation working through a product development partnership model to deliver a portfolio of accessible medicines with the power to treat, prevent, and eliminate malaria.

The new treatment, also known as Riamet® Baby in some countries, was developed through an MMV and Novartis collaboration to treat the potentially deadly mosquito-borne disease. MMV said in a press statement that the drug has been approved by “Swissmedic as the first malaria medicine for newborns and young infants.”

According to MMV, until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilogrammes, leaving a treatment gap. The developers further indicated that these babies have instead been treated with formulations intended for use in older children, “which may increase the risk of overdose and toxicity.”

“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 optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.”

The developers indicated that Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic.

Vas Narasimhan, the Chief Executive Officer of Novartis, 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,” he added.

Mr Umberto D'Alessandro, the Director of Medical Research Council (MRC) Unit, The Gambia at the London School of Hygiene and Tropical Medicine, on the other hand, noted that the “available malaria treatments have only been properly tested in children aged at least six months because smaller infants are usually excluded from treatment trials.”

“That matters because neonates and young infants have immature liver function and metabolise some medicines differently, so the dose for older children may not be appropriate for small babies,” he added. We couldn’t get a comment from the Ministry of Health by press time.

Officials in the malaria control division said they were yet to get more information about the development. Assessment of the drug Developers of the drug, however, noted that the eight African countries that participated in the assessment are now expected to issue rapid approvals under the Swiss agency’s Marketing Authorisation for Global Health Products procedure.

The countries include Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda. According to information from the Ministry, around 16 malaria deaths are reported in Uganda daily, with 10 happening in children under five. The government has recently launched a malaria vaccine for children, but this is not available for children under six months.

Novartis approval

Novartis, said around 30 million babies are born in areas of malaria risk in Africa every year, with one survey across West Africa reporting infections ranging between 3.4 percent and 18.4 percent in infants younger than six months old, Novartis said. The treatment will be distributed on a largely not-for-profit basis.

‘‘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.

 
Provided by SyndiGate Media Inc. (Syndigate.info).

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