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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