The US Food and Drug Administration (FDA) has approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and paediatric patients aged three years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
Admelog is the first short-acting insulin approved as a ‘follow-on’ product (submitted through the agency’s 505(b)(2) pathway).
Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control through treatment with insulin, a common treatment, can reduce the risk of some of these long-term complications.
‘One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,’ said FDA Commissioner, Scott Gottlieb, MD.
Admelog was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and / or effectiveness of the proposed product, if such reliance is scientifically justified. The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients.
In the case of Admelog, the manufacturer submitted a 505(b)(2) application that relied, in part, on the FDA’s finding of safety and effectiveness for Humalog (insulin lispro injection) to support approval. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for Humalog was scientifically justified and provided Admelog-specific data to establish the drug’s safety and efficacy for its approved uses. The Admelog-specific data included two phase 3 clinical trials which enrolled approximately 500 patients in each.