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