Admelog Approved as First Follow-On to Humalog
December 11, 2017 – The U.S. FDA has approved Admelog® (insulin lispro) injection, manufactured by Sanofi SA, as the first follow-on biologic to Eli Lilly’s Humalog® (insulin lispro) injection. Both drugs are approved to treat type 2 diabetes in adults, and type 1 diabetes in adults and in children at least three years old. Admelog is the first follow-on short-acting insulin product to receive FDA approval.
An estimated 30 million Americans live with diabetes, according to the Centers for Disease Control and Prevention (CDC). Admelog is intended to help individuals with diabetes control their blood sugar after meals. For patients who have type 1 diabetes, the combined use of a short-acting insulin like Admelog alongside a long-acting insulin product is necessary to maintain proper blood glucose. Admelog can be administered in three different ways: subcutaneous injection, subcutaneous infusion (such as with an insulin pump), and intravenous infusion. Recommended dosing is based on the route of administration and the patient’s individual needs.
Admelog was approved based on FDA findings regarding the safety and effectiveness of Humalog, as well as supporting data from Admelog-specific clinical trials. It will be available in 10mL vials and prefilled 3mL SoloStar pens. Sanofi has announced that pricing information will be provided at launch, which is anticipated in early 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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