Admelog was approved through an abbreviated pathway that relies on FDA evidence demonstrating that a previously approved drug is safe and effective. Drugs that are approved through this process are considered “follow-on” products to the original drug. Admelog’s approval relied on previous safety and efficacy data for Humalog.   The manufacturer was able to demonstrate that the data for Humalog was justified and included two phase 3 clinical trials for Admelog that included 500 patients each. As a short-acting insulin, Admelog is typically administered at mealtimes to control blood glucose levels after eating and can also be used in insulin pumps for both background and mealtime insulin needs.

Of note, drugs approved through this abbreviated pathway can lower the cost of drug development, which may lead to lower costs for patients. FDA Commissioner Scott Gottlieb, MD stated, “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.” Pricing information is not available at this time as the product is not yet available in pharmacies for dispensing.

Click here to the read the full announcement released by the FDA.