24 Jul 2018

New malaria drug gets approval in the US

7:42 am on 24 July 2018

A new malaria drug has been cleared for use by American medical authorities - the first such pill to get approval in 60 years.

An Indian man holding his baby suffering from malaria at an emergency ward at a children's hospital in Allahabad. September 3, 2015.

A baby being treated in a hospital in India. Recurring malaria hits children hard, with both their health and prospects affected longterm. Photo: AFP

The new medicine is for the recurring form of malaria, which makes 8.5 million people ill each year.

Recurring malaria - caused by the parasite plasmodium vivax - is the most common type of malaria outside Sub-Saharan Africa.

It is a particular challenge to get rid of as it can remain dormant in the liver for years before reawakening many times.

Children can be particularly at risk, getting several bouts of malaria from a single bite, missing lots of school and getting weaker each time they get the disease.

Now the Food and Drug Administration (FDA) in the United States has given the seal of approval to tafenoquine, a drug that can flush the parasite out of its hiding place in the liver with a single dose.

The drug has been developed by GlaxoSmith Kline, in partnership with the Medicines for Malaria Venture headed by New Zealand doctor David Reddy.

The US FDA's approval of the drug was a significant contribution toward global efforts to eradicate malaria, Dr Reddy said.

The drug was particularly good because the patients needed to take just one dose to counter the relapsing form of marlaria, he said.

"Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most."

There is already a medication that can be used to get rid of malaria hiding in the liver called primaquine, but it often needs to be taken for 14 days.

Doctors say many people feel better after just a few days and stop taking the pills, allowing the parasite to awaken at a later date.

Scientists have described the single dose tafenoquine as a "phenomenal achievement."

Dr Hal Barron, president of research and development at GSK, the company that manufactures the drug, said: "The approval of Krintafel [the brand name for tafenonquine] is a significant milestone for people living with relapsing malaria.

"Together with our partner, Medicines for Malaria Venture, we believe Krintafel will ... contribute to the ongoing effort to eradicate this disease."

Tafenonquine has been in existence since the 1970s but working with Medicines for Malaria, GSK has repurposed the drug so it can be used to get rid of malaria parasites in the liver.

The FDA says the drug is effective and approves it for use in the United States but points out there are important side effects to be aware of.

For example, the drug could cause severe anaemia in people with an enzyme problem, called G6PD deficiency.

There are also concerns it could be a problem for people with psychiatric illnesses.

But despite these cautions there is hope the drug, together with bed nets and other precautions, will help reduce the amount of vivax malaria around the world.

The next step will be for the drug to be assessed by regulators in countries where this form of malaria is a significant problem.