FDA Approves Eton’s Oral Hydrocortison Solution for Children with Adrenocortical Insufficiency

Rare Daily Staff

The U.S. Food and Drug Administration approved Eton Pharmaceuticals. Khindivi, a hydrocortisone oral solution, as a replacement therapy for pediatric patients with the rare condition adrenocortical insufficiency five years of age and older.

Adrenocortical insufficiency is a serious condition in which the adrenal glands do not produce sufficient cortisol. Eton estimates that there are more than 5,000 adrenal insufficiency patients in the United States between the ages of 5 and 17.

Khindivi is the only FDA-approved oral solution formulation of hydrocortisone. It is designed to eliminate the need to split or crush tablets, and to offer simple and accurate dosing specifically tailored to each patient’s needs. The ready-to-use solution does not require refrigeration, mixing, or shaking. It is intended as a therapy option for patients who have difficulty swallowing tablets or have special administration needs, such as patients with a gastric tube.

Khindivi will be available in the United States exclusively through Anovo, a specialty pharmacy that serves patients with rare and chronic conditions.

“For families facing the daily challenges of pediatric congenital adrenal hyperplasia (CAH), timely access to the right treatments is critical,” said Dina Matos, executive director of the CARES Foundation, which is solely focused on the CAH community. “The introduction of Khindivi is a significant advancement, particularly because accurately splitting pills to achieve proper dosing for children has long been a struggle. The ability to dose patients more accurately is critical for treatment outcomes.”