Date: 2017-12-11
Type of information: Granting of a Market Authorisation in the US
Product name: Insulin lispro Sanofi/Admelog®
Compound: insulin lispro
Therapeutic area: Metabolic diseases
Action mechanism:
- biosimilar/insulin analog. Insulin lispro is a fast-acting insulin analogue which is absorbed more rapidly by the body and can therefore act faster than human insulin.
- Admelog® can be used to help patients with diabetes control their blood sugar. Short-acting insulin products are generally, but not always, administered just before meals to help control blood sugar levels after eating. These types of insulin products can also be used in insulin pumps to meet both background insulin needs as well as mealtime insulin needs. This is in contrast to long-acting insulin products, like insulin glargine, insulin degludec and insulin detemir, which are generally used to provide a background level of insulin to control blood sugars between meals, and are administered once or twice a day. While both types of insulin products can play important roles in the treatment of types 1 and 2 diabetes mellitus, patients with type 1 diabetes require both types of insulin while patients with type 2 diabetes may never need a short-acting insulin product.
- Admelog® can be administered by injection under the skin (subcutaneous), subcutaneous infusion (i.e., via insulin pump), or intravenous infusion. Dosing of Admelog should be individualized based on the route of administration and the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.
Company: Sanofi (France)
Disease:
- type 1 diabetes mellitus
- type 2 diabetes mellitus
Latest news:
- • On December 11, 2017, the FDA approved Admelog® (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 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). The drug was first 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.
- The most common adverse reactions associated with Admelog in clinical trials was hypoglycemia, itching, and rash. Other adverse reactions that can occur with Admelog include allergic reactions, injection site reactions, and thickening or thinning of the fatty tissue at the injection site (lipodystrophy). Admelog® received tentative approval from the FDA on Sept. 1, 2017 and is now being granted final approval.
- • On September 1, 2017, Sanofi announced that the FDA granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, to improve glycemic control in adults and children with diabetes mellitus. The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the U.S., including data from a clinical development program involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients.
- • On July 19, 2017, the European Commission has granted market authorisation for Insulin lispro Sanofi for the treatment of diabetes mellitus.
- • On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Insulin lispro Sanofi, intended for the treatment of diabetes mellitus. Insulin lispro Sanofi will be available as a solution for injection (100 units/ml). The drug is a biosimilar medicinal product. It is highly similar to the reference product
Humalog® (insulin lispro), which was authorised in the EU on 30 April 1996. Data show that Insulin lispro Sanofi has comparable quality, safety and efficacy to Humalog.
The recommendation is based on a clinical development program involving over 1,000 adults with type 1 or type 2 diabetes. This program comprised a pharmacokinetic / pharmacodynamic (PK/PD) Phase 1 study to evaluate the product’s similarity in exposure and activity compared to insulin lispro 100 Units/mL as currently approved in the U.S. and EU, two multi-center Phase 3a clinical trials (SORELLA 12 and SORELLA 2) evaluating its safety and efficacy compared to insulin lispro 100 Units/mL as currently approved in the U.S. and EU in adults with type 1 or type 2 diabetes, and a safety study in insulin pumps in adults with type 1 diabetes.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-09-01/2017-12-11
UE authorization: 2017-07-19
Favourable opinion UE: 2017-05-18
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
