Novartis Gets Approval for Malaria Drug for Children

Post by : Monika

Photo: Reuters

Swiss company Novartis has made a big achievement in the fight against malaria. It has developed a new medicine called Coartem Baby, and it has now been approved in Switzerland. This medicine is made specially for infants and very young children.

Until now, there was no malaria treatment created just for newborn babies. This new medicine will help protect millions of small children, especially in Africa, where malaria is still a big problem.

What Is Coartem Baby?

Coartem Baby contains the same two active ingredients used in the adult version of Coartem — artemether and lumefantrine. These have been used safely for many years.

But Coartem Baby is specially made for babies weighing 2 to 5 kilograms — about 4½ to 11 pounds. It is given in the form of cherry-flavored tablets that can dissolve easily in breast milk or water. This makes it easier for parents to give the medicine to babies.

Why This Medicine Matters for Infants

Before this, doctors had to give babies medicines meant for older children or adults. This could be dangerous. The baby might get too much or too little medicine, which could make them worse instead of better.

Also, most malaria medicines were only tested on children older than six months. So no one knew how safe they were for newborns or very young infants.

Now, Coartem Baby gives doctors a proper and safe option for the youngest patients.

What Is Malaria?

Malaria is a disease spread by the bite of infected mosquitoes. It causes fever, chills, tiredness, and sometimes serious illness or death.

In 2023, around 263 million people got malaria around the world. Almost 600,000 people died from it. Three out of every four deaths were children under five years old. Most of these children lived in Africa, where malaria is very common.

Why Coartem Baby Is a Big Step

Each year, about 30 million babies are born in Africa in places where malaria spreads easily. In some areas, as many as 1 in 5 infants get malaria within their first six months of life.

There was no approved medicine for babies under 5 kg. Doctors had to make guesses about how much medicine to give.

Coartem Baby now gives a correct and safe dose for babies, which helps doctors treat them better and prevent deaths.

How It Was Made and Tested

Novartis developed this medicine with help from a health organization called Medicines for Malaria Venture (MMV). MMV provided both scientific knowledge and financial support.

The medicine was tested in eight African countries — Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda. These tests showed that Coartem Baby works safely and effectively in young infants.

Based on the results, the Swiss health authority gave its approval for Coartem Baby.

What Happens Next?

The same eight African countries that helped with the testing are expected to approve the medicine quickly. They use a fast process for medicines that are important to public health.

After approval, Coartem Baby can be sold and used in hospitals and clinics in those countries.

Cost and Availability

Novartis has promised to sell Coartem Baby at cost, meaning they will not try to make a profit from it.

This helps poor countries buy the medicine at a low price so that more babies can be treated. This is part of Novartis’s long-standing effort to make life-saving treatments more available in areas that need them most.

What Novartis and MMV Say

Vas Narasimhan, the CEO of Novartis, said he was proud of this new medicine. He said that even the smallest and most vulnerable babies deserve safe treatment.

Martin Fitchet, the head of MMV, said that Coartem Baby is a much-needed tool in the fight against malaria and that it helps a group that was left out until now.

Why Other Medicines Weren’t Good Enough

Most malaria drugs were only tested for older children and adults. But newborns and small babies are very different. Their bodies are still growing. Their liver, kidneys, and immune system don’t work the same as in bigger children.

So giving them the wrong amount of medicine — even a small mistake — can be very risky.

Coartem Baby was designed and tested just for infants between 2 and 5 kg, which makes it safer and more effective for them.

What Did the Research Show?

A special trial named CALINA tested the correct dose for babies. The results showed that the drug works well to treat simple malaria infections caused by a parasite called Plasmodium falciparum. This parasite is the most common cause of malaria in Africa.

The drug is for mild malaria only and should not be used in severe or emergency cases.

Malaria Still a Big Problem

In many parts of sub-Saharan Africa, malaria is still a leading cause of death in children under five. Even though vaccines and mosquito nets help, treatment is still important.

Medicines like Coartem Baby give newborns a better chance to survive until their immune systems grow stronger.

Novartis’s History in Fighting Malaria

Novartis has worked on malaria since 1999. It has already delivered over 1.1 billion treatments, mostly in low-income countries. Half of these treatments were for children.

Even if funding from global health groups goes down, Novartis says it will keep making 28 million malaria treatments each year, to help those in need.

What Health Experts Say

• Many global health leaders said that making a medicine for babies under 5 kg was a huge missing piece in malaria care.
• Now, with Coartem Baby, health workers have better tools to treat malaria from birth onward.
• Groups like the World Health Organization also support this move, as it helps more children get fair and equal healthcare.

What Comes Next?

• Once approved in the African countries, clinics and hospitals will start receiving the medicine.
• Doctors and nurses will be trained to give the right dose and teach parents how to mix and use the sweet, cherry-flavored tablet.
• This will help save many lives in the months and years to come.
• Coartem Baby is the first malaria drug made specially for tiny babies under 5 kg.
• It is now approved in Switzerland and will soon be available in eight African countries.
• It fills an important gap in malaria treatment for infants.
• It’s safe, effective, and designed to be easy to give to newborns.
• Novartis and MMV worked together to develop it and keep the cost low.