FDA approves Apidra for pediatric use

Article

The US Food and Drug Administration (FDA) has approved insulin glulisine (Apidra) to treat diabetes in children ages 4 and older, announced the drug's manufacturer, sanofi-aventis.

The US Food and Drug Administration has approved insulin glulisine (Apidra) to treat diabetes in children ages 4 and older, announced the drug's manufacturer, sanofi-aventis.

The approval is based on an FDA review of a 26-week, phase III, open-label study comparing Apidra with insulin lispro among 572 children ages 4 to 17 with type 1 diabetes. Changes in HbA1c were similar in both treatment groups (+0.10% for glulisine vs. +0.16% for lispro), as was postprandial glycemic control during endpoint.

Additionally, 7.2% of participants in the glulisine group and 8.1% of participants in the lispro group reported the adverse event of hypoglycemia, according to the manufacturer.

Recent Videos
Sensory play for children with autism, with Joshua Feder, MD
Stephanie Chao, MD
Feasibility of ambulatory blood pressure monitoring in primary care | Carissa Baker-Smith, MD, MPH
Tina Tan, MD
Camille Walker CPNP-PC, MSN, CPNP Sacheen D. Harris MSN, CPNP-PC
Danielle Van Damme, DNP, CPNP-AC
Karen Y. Capusan, DNP, CPNP-PC
Discussion: AAP's opioid for acute pain clinical practice guideline with Jessica Spruit, DNP
Bobbie Monaco, MSN, CPNP-PC
Measles outbreaks: 223 cases reported in Texas | Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN
© 2025 MJH Life Sciences

All rights reserved.