(Reuters) -AstraZeneca said on Friday its once-weekly diabetes medicine Bydureon was approved in the United States for use in patients as young as age 10, expanding the drug’s access to a critical population.
Chemically called exenatide, the drug is an injectable suspension and has been approved by the U.S. Food and Drug Administration (FDA) for use in 10-year to 18-year olds who have type-2 diabetes, the Anglo-Swedish drugmaker said.
Type-2 diabetes is the most commonly occurring form of the condition where the body cannot properly use or make enough of the hormone insulin, to convert blood sugar into energy.
The drug aims to help reduce blood sugar levels along with diet and exercise.
The U.S. approval comes about a month after data from a late-stage study showed the drug significantly reduced blood glucose levels in adolescents compared to placebo. Bydureon is already approved in the country for adults with type-2 diabetes.
“This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option,” said AstraZeneca senior executive Mene Pangalos.
The only other non-insulin options available for adolescents with diabetes are metformin and liraglutide, and they usually have to be taken daily. A lower frequency of use can help check chemical toxicity from frequent intake of medicines.
Bydureon belongs to the class of GLP-1 receptor agonist medicines that activate the GLP-1 protein in the pancreas and stimulate the production of insulin.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Bernard Orr and Uttaresh.V)