First Short-Acting Insulin Approved as a "Follow-On" Product

Admelog was approved through an abbreviated approval pathway
Admelog was approved through an abbreviated approval pathway

The Food and Drug Administration (FDA) announced the final approval of Admelog (insulin lispro injection; Sanofi Aventis) indicated to improve glycemic control in adults and children aged ≥3 years with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus. 

Admelog is a short-acting insulin that was tentatively approved in September 2017 as a "follow-on" product through the FDA's 505(b)(2) pathway, an abbreviated approval pathway. New Drug Applications (NDA) submitted through this track can use the FDA's finding that a previously approved drug was safe and effective, or rely on published evidence supporting the safety and/or efficacy of the proposed product if scientifically justified. The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients.

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For Admelog, the Company submitted an application that relied on the safety and efficacy data for Humalog (insulin lispro injection; Lilly) to support its approval. Admelog-specific data was also provided to establish the drug's safety and efficacy for its approved uses, including two Phase 3 clinical trials of approximately 1,000 total patients.

Admelog can be given as a subcutaneous injection, subcutaneous infusion (eg, insulin pump), or intravenous infusion. Hypoglycemia, itching, and rash were reported as the most common side effects in clinical trials. 

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