FDA approves diabetes treatment for children over one year of age

The Food and Drug Administration (FDA) approved the use in young children of the treatment Tzield, used to slow the progression of type 1 diabetes, the French pharmaceutical giant Sanofi announced Wednesday.

Until now, the treatment in the country was reserved for adults and children over eight years of age. With the new measure, it will be able to be used in children over one year old, AFP reported.

Treatment does not cure, but slows disease progression

The agency's approval "underscores the importance of acting on the immune system at an early stage of autoimmune type 1 diabetes, in order to influence the natural progression of the disease by slowing the loss of insulin production by the pancreas," Christopher Corsico, global head of development at Sanofi, explained in a statement.

The treatment does not cure but slows the progression of this chronic disease by slowing the autoimmune reaction, the drugmaker explains.

It acts when diabetes is detectable but before the onset of symptoms (phase 2) to slow its progression to the clinical phase of the disease (phase 3), which requires insulin injections to lower blood glucose.

A higher risk of rapid and unpredictable progression

Kimber Simmons, associate professor of pediatrics at the Barbara Davis Center in the United States, stressed to AFP that "this is especially important because these children often present the highest risk of rapid and unpredictable progression."

In January, the European Commission approved the application of the same Sanofi treatment under the name "Teizeild," only from the age of eight.

Sanofi acquired U.S. biotech company Provention Bio in 2023 for $2.9 billion, seeking to strengthen its position in diabetes and immune disease treatments.