New malaria treatment for newborns and young infants to be rolled out in weeks

ABC NEWS (Australia)

A malaria treatment designed for babies and very young children has been approved for use for the first time, and is expected to be rolled out in African countries within weeks. The treatment has been touted as an advance against the deadly disease that kills hundreds of thousands of people each year, nearly all in Africa. Martin Fitchet is the CEO of Medicines for Malaria Venture, one of the organisations involved in developing the drug.

Transcript

00:00It has been a long time coming, but it's great to have this. It's a real breakthrough

00:05to have the first regulatory approval and now the ability to roll out the first malaria

00:11treatment specifically studied and designed for the youngest and most vulnerable children

00:17at risk of malaria.

00:19What obstacles had to be overcome to develop this drug?

00:22Well, it's incredibly difficult to develop drugs in the very youngest and the very most

00:28vulnerable children, so we must remember that malaria is still a deadly disease. Around

00:3430 million children are born each year into areas at risk of malaria, and of 600,000 people

00:42who die annually from malaria, around three-quarters are children under five. Of those children

00:49under five, most age groups have been studied, but there's been a very most vulnerable age

00:55group, which is those under six months old, the newborns and young infants that had yet

00:59to be studied.

01:00And this program and this regulatory approval fills that critical treatment gap.

01:06The reason it's taken so long is because these are very, very difficult studies to do.

01:11They're very difficult patients to treat.

01:15They need a global collaborative partnership that includes the communities, the doctors

01:21and also our global pharmaceutical partner Novartis, working together to get everything

01:27right, to engage with patients and to execute the studies.

01:31Also, children of this age, the youngest and most vulnerable, are often the last to be studied

01:36in drug development programs. And so this is really great news that we now have this approval.

01:41What's that frustrating for you? Because obviously it's different to vaccines potentially, but

01:46we saw how quickly COVID treatments were rushed out because of the need for it. And when you're

01:51seeing young and vulnerable children suffer from malaria, the impatience within must just grow.

01:59It's really important to understand that the drugs for malaria are always developed in children.

02:05They have been developed in children for many decades. But it's also important to understand that the

02:11very youngest children, those say under six months, the most vulnerable, they haven't yet been studied.

02:17It's a very vulnerable group. It's not the largest group of children, but it's a very important

02:21treatment gap to fill. So although it has taken some time to get here, it's a really important

02:27milestone because now we can cover the whole spectrum of ages of children. And as I said before,

02:33the children are the ones who are at most risk of dying from malaria. So this is a major advance.

02:38And you're saying that this can be rolled out within weeks. How confident are you that timeline

02:44will be kept to? Well, this is the utmost urgency for everybody involved in this program.

02:51We've just had approval from Swiss Medic, which is a Swiss regulatory authority. This is a really

02:57important catalyst because it now allows us to register the drug across the African nations with the

03:03highest burden of disease, initially eight countries. And we are going to do this now with the utmost

03:09urgency. We're looking to launch the product towards the end of this year and get it delivered and

03:14available in Africa as soon as possible thereafter.

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