Date: 2013-11-15
Type of information: Granting of a Market Authorisation in the EU
Product name: Invokana®
Compound: canagliflozin
Therapeutic area: Metabolic diseases
Action mechanism: SGLT2 inhibitor. Canagliflozin is an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin has been shown to block the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
Company: J&J (USA)
Disease: type 2 diabetes
Latest news: * On June 26, 2012, Janssen-Cilag International, a J&J subsidiary, has announced that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of canagliflozin for the treatment of adult patients with type 2 diabetes. The MAA submission is supported by a comprehensive global Phase III clinical development programme, which included nine multicentre, randomised clinical studies that enrolled approximately 10,300 patients. The Phase III programme evaluated the safety and efficacy of canagliflozin across the spectrum of adult patients with type 2 diabetes and included placebo- and active comparator-controlled studies. The programme also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease. * On September 19, 2013, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Invokana® (100 mg and 300 mg film-coated tablet) intended for the treatment of type 2 diabetes. The indication recommended by the CHMP is as follows:“Invokana® is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:Monotherapy (When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications).Add-on therapy (Add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.The most common side effects with Invokana are hypoglycaemia (when used in combination with insulin or a sulphonylurea), vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria (i.e., urinary frequency). A pharmacovigilance plan for Invokana® will be implemented as part of the marketing authorisation.The Marketing Authorisation Application submission was supported by a comprehensive global Phase 3 clinical programme, which enrolled more than 10,300 patients in nine studies, and is one of the largest late-stage development programmes for an investigational pharmacological product for the treatment of type 2 diabetes submitted to health authorities to date. It assessed the efficacy and tolerability of canagliflozin across the spectrum of adult type 2 diabetes management, in patients who need further glucose control as a single agent (monotherapy), in combination with metformin, and in combination with other glucose-lowering agents, including insulin.Three studies have compared canagliflozin to current standard treatments; two of which compared canagliflozin to sitagliptin and the other to glimepiride. The Phase 3 programme also included three large studies in special populations; older patients with type 2 diabetes, patients with type 2 diabetes who had moderate renal impairment, and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.* On January 10, 2013, Janssen Research & Development has announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 10 – 5 to recommend approval for canagliflozin, proposed trade name Invokana®, to treat type 2 diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program. Data presented at advisory committee meeting included results from the comprehensive global Phase 3 clinical program, which enrolled 10,285 patients in nine studies; it is the largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. Canagliflozin was evaluated at 100 mg and 300 mg once-daily doses in placebo- and active comparator-controlled studies, as well as three large studies in special populations: older patients, patients with moderate renal impairment, and patients who had or were at risk for cardiovascular disease. Results showed that in addition to the improvements in glycemic control, both doses of canagliflozin were associated with weight loss and reductions in blood pressure across clinical studies. Canagliflozin was generally well tolerated. It has specific safety and tolerability issues that were well characterized in this development program (such as the genital mycotic infections, urinary tract infections) and can be well managed by the physician and by the patient for some of these issues.
Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.
Patents:
Submission of marketing authorization application USA : 2012-05-31
Submission of marketing authorization application UE: 2012-06-26
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-03-29
UE authorization: 2013-11-15
Favourable opinion UE: 2013-09-19
Favourable opinion USA: 2013-01-10
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
