Date: 2015-07-03
Type of information: Granting of a Market Authorisation in Japan
Product name: Toujeo® (U300)/Lantus® XR (Japan)
Compound: insulin glargine (rDNA origin) injection 300 U/mL
Therapeutic area: Metabolic diseases
Action mechanism: protein. Toujeo® is a next-generation, once-daily basal insulin based on insulin glargine, a long acting insulin analogue. Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Company: Sanofi (France)
Disease: type 1 diabetes type 2 diabetes
Latest news: * On July 3, 2015, Sanofi announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing authorization for insulin glargine [rDNA origin] injection, 300 U/mL, a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus, where treatment with insulin is needed. Known as Toujeo® in the U.S. and Europe, the new insulin treatment will be available in Japan under the trade name Lantus® XR. The MHLW decision is based on the results of the EDITION Phase III study program, an extensive series of studies evaluating the efficacy and safety of Toujeo / Lantus XR compared with Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. The EDITION program established the favorable Toujeo / Lantus XR efficacy and safety profile and included the EDITION JP 1 and JP 2 studies,6, 7 which involved over 450 Japanese people with type 1 or type 2 diabetes. Toujeo is now available in the U.S., Germany, Denmark and the Netherlands and has been registered in Australia. The product will become available in other countries in the coming months. * On April 28, 2015, Sanofi announced that the European Commission has granted marketing authorization in Europe for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) for the treatment of type 1 and type 2 diabetes mellitus in adults. The European Commission's decision to grant marketing authorization in Europe for Toujeo is based on results from the EDITION clinical trial program, a series of worldwide Phase III studies evaluating the efficacy and safety of Toujeo compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. Blood sugar control with Toujeo® was comparable to Lantus®, with a favorable safety profile. The incidence of confirmed hypoglycemia was lower with Toujeo as compared to Lantus, both at any time of the day and at night, in people with type 2 diabetes.7 Toujeo also demonstrated more stable and more predictable glycemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus in people with type 1 diabetes.8-10 "Many people living with diabetes and requiring insulin are still not achieving adequate blood sugar control," said Professor Robert Ritzel, Head of the Clinic of Endocrinology, Diabetology and Addiction Medicine, Klinikum Schwabing, Städtisches Klinikum München GmbH, Munich, Germany. "By providing glycemic stability and less variability, as well as reducing hypoglycemic events in people with type 2 diabetes, Toujeo provides a new way to address these unmet needs." Marketing authorization in Europe for Toujeo is applicable to the 28 member states of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the February 26, 2015 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Toujeo has been approved by the U.S. Food and Drug Administration (FDA) and is under review by other regulatory authorities around the world. * On February 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo® has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) with low within-individual, within-day blood sugar variability. The CHMP positive opinion of Toujeo® is based on results from the EDITION clinical trial program, a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo® compared to Lantus® in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. Once approved, Toujeo will be available in the Toujeo® SoloSTAR®, a disposable prefilled pen which contains 450 insulin units (IU), and it has a maximum single injection dose of 80 IU. The CHMP adopted a group of variations recommending the addition of a new formulation to the marketing authorisation of the medicinal product Optisulin and a change of the invented name to Toujeo®. The new formulation of Toujeo is a higher strength insulin (300 U/ml).Insulin glargine was first authorised as a 100 U/ml formulation as Lantus and Optisulin in the EU in June 2000. * On February 26, 2015, Sanofi announced that the FDA approved Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo® is expected to be available in the U.S. at the beginning of Q2 2015. The approval of Toujeo® was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2). In the clinical trial program leading to approval, once-daily Toujeo® was compared to that of once-daily Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) in open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with 6 months safety extension. Toujeo® will be available in the Toujeo SoloSTAR®, a disposable prefilled pen which contains 450 units of Toujeo® and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR®. The maximum single injection dose of 80 IU meets the needs of the vast majority of patients on basal insulin in the U.S., who require 80 IU or less per day. * On July 8, 2014, Sanofi announced that the FDA has accepted for review the company’s New Drug Application (NDA) for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL),an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo® by the European Medicines Agency (EMA) for EU countries on May 27, 2014. The NDA for Toujeo® is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo® in over 3,500 people from broad and diverse diabetes populations. Sanofi anticipates a regulatory decision for marketing authorization for Toujeo® in the U.S. in the first half of 2015. * On May 27, 2014, the European Medicines Agency (EMA) accepted Sanofi’s marketing authorization dossier for Toujeo® (insulin glargine (rDNA origin) injection 300 U/mL), for EU countries. Sanofi has submitted the New Drug Application (NDA) for insulin glargine [rDNA origin] injection, 300 U/mL to the FDA. The formal acceptance of the submission is pending.
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: 2015-02-26
UE authorization: 2015-04-28
Favourable opinion UE: 2015-02-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
