The Janssen Pharmaceutical Companies of Johnson & Johnson today appear that the European Commission (EC) has accepted approval to amend the INVOKANA® (canagliflozin) and VOKANAMET® (canagliflozin and metformin) labelling to accommodate changes to the adumbration account for the assay of adults with comparatively controlled type 2 diabetes mellitus (T2DM) as an accessory to diet and exercise. The accommodation agency that the artefact advice now includes abstracts on the abridgement in above adverse cardiovascular (CV) contest (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with blazon 2 diabetes mellitus (T2DM) who had either a history of CV ache or at atomic two CV accident factors, in accession to the absolute abstraction after-effects on convalescent glycemic control.
“We achievement this approval will not alone accommodate clinicians with a added abundant overview of canagliflozin but additionally advice them back authoritative a assay decisions which are best adapted for their patients. Blazon 2 diabetes mellitus is one of the best accepted forms of diabetes and accounts for the majority of diabetes cases common so it is acutely important that we abide convalescent outcomes for these patients,” said Dr. Jose Antonio Buron, Vice-President Medical Affairs EMEA, Janssen-Cilag Farmacêutica, Lda.
The EC’s accommodation follows a advocacy from the Committee for Medical Articles for Human Use (CHMP) that was based on abstracts from the CANVAS Program, the bigger completed CV outcomes balloon to date for an SGLT2 inhibitor.1 The study, which included over 10,000 patients started in 2009, met its primary endpoint and showed canagliflozin decidedly bargain the accumulated accident of CV death, myocardial infarction and non-fatal stroke, against placebo in developed patients with T2DM who had either a history of CV ache or at atomic two CV accident factors.1
Canagliflozin additionally decidedly bargain the accident of hospitalisation for affection abortion and accustomed bigger renal outcomes.1 Adverse contest appear in the CANVAS Program were about constant with the accepted assurance contour of canagliflozin.1 However, the abstraction begin that, in patients with T2DM who had accustomed CV ache or at atomic two accident factors for CV disease, canagliflozin was associated with an about 2-fold added accident of lower limb amputation with the amount of amputation over accepted of affliction actuality 0.63/100 accommodating years for canagliflozin against 0.34/100 accommodating years for placebo which corresponds to an added accident of 0.29/100 accommodating years.1 The accident of amputations beyond the chic has ahead been advised by the EMA, and this is reflected in a admonishing in the labelling of SGLT2 inhibitors.
Canagliflozin was accustomed in the European Union by the European Commission in November 2013 and is adumbrated for the assay of adults with comparatively controlled blazon 2 diabetes mellitus.2 Approval was based on a absolute all-around Phase 3 analytic balloon programme.
Janssen has a affiliation with Mundipharma, who is the absolute benefactor for both INVOKANA® and VOKANAMET® in countries in the European Economic Area (EEA) and Switzerland area the articles currently accept appraisement and agreement status. Mundipharma has absolute rights to promote, distribute, and advertise both articles through its arrangement of absolute associated companies. This is with the barring of Spain, area the artefact is co-promoted by both Janssen and Mundipharma.
Notes to editors
About the CANVAS Program
The CANVAS Program (N=10,142) comprises the two ample canagliflozin CV aftereffect studies, CANVAS and CANVAS-R, and includes a pre-specified chip assay of these two studies to appraise the abeyant for CV aegis of canagliflozin in patients with T2DM who had either a above-mentioned history of CV ache or at atomic two CV accident factors. The chip assay additionally evaluated the furnishings of canagliflozin on renal and assurance outcomes.1
Canagliflozin met the primary aftereffect by decidedly abbreviation the ante of the blended of above adverse CV contest (MACE) comprised of CV mortality, non-fatal myocardial infarction (MI), or non-fatal achievement (26.9 vs. 31.5/1000 patient-years, hazard arrangement (HR) 0.86; 95% aplomb breach (CI 0.75-0.97; P<0.0001 for noninferiority; P=0.0158 for superiority) compared with placebo, respectively. All 3 apparatus of MACE blended (CV death, non-fatal MI, and non-fatal stroke) apparent point estimates of aftereffect suggesting account with canagliflozin.1
Adverse contest appear in the CANVAS Program were about constant with the accepted assurance contour of canagliflozin. However, the abstraction begin that, in patients with blazon 2 diabetes who had accustomed CV ache or at atomic two accident factors for CV disease, canagliflozin was associated with an about 2-fold added accident of lower limb amputation with the amount of amputation over accepted of affliction actuality 0.63/100 accommodating years for Invokana against 0.34/100 accommodating years for placebo which corresponds to an added accident of 0.29/100 accommodating years.1 The accident of amputations beyond the chic has ahead been advised by the EMA, and this is reflected in a admonishing in the labelling of SGLT2 inhibitors.
These after-effects served the base for Janssen’s acquiescence to the European Medicines Agency (EMA), gluttonous to aggrandize labelling for INVOKANA® and VOKANAMET® to accommodate absolute abstracts on cardiovascular anguish and mortality.
INVOKANA® (canagliflozin) is an oral, once-daily medication which belongs to a new chic of medications alleged sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors assignment by inhibiting SGLT2, which promotes the accident of glucose via the urine, blurred claret glucose levels in adults with blazon 2 diabetes. Canagliflozin was accustomed in the European Union by the European Commission in November 2013. INVOKANA® is adumbrated for the assay of adults with comparatively controlled type 2 diabetes mellitus as an accessory to diet and exercise. Approval was based on a absolute all-around Phase 3 analytic balloon programme.2
VOKANAMET® (a fixed-dose aggregate of canagliflozin and metformin) is accustomed in the European Union for the assay of adults with comparatively controlled type 2 diabetes mellitus as an accessory to diet and exercise. VOKANAMET® combines two articulate glucose-lowering alleviative articles with altered and commutual mechanisms of action.3
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are alive to actualize a apple after disease. Transforming lives by award new and bigger means to prevent, intercept, amusement and cure ache inspires us. We accompany calm the best minds and accompany the best able science.
We are Janssen. We coact with the apple for the bloom of anybody in it. Learn added at www.janssen.com/emea. Follow us at www.twitter.com/JanssenEMEA.
Janssen-Cilag International N.V. is allotment of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This columnist absolution contains “forward-looking statements” as authentic in the Private Securities Litigation Reform Act of 1995 apropos INVOKANA® and VOKANAMET® labelling. The clairvoyant is cautioned not to await on these advanced statements. These statements are based on accepted expectations of approaching events. If basal assumptions prove inaccurate or accepted or alien risks or uncertainties materialize, absolute after-effects could alter materially from the expectations and projections of Janssen-Cilag International N.V., any of the added Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not bound to: challenges and uncertainties inherent in artefact analysis and development, including the ambiguity of analytic success and of accepting authoritative approvals; ambiguity of bartering success; accomplishment difficulties and delays; competition, including abstruse advances, new articles and patents accomplished by competitors; challenges to patents; artefact ability or assurance apropos consistent in artefact recalls or authoritative action; changes in behavior and spending patterns of purchasers of bloom affliction articles and services; changes to applicative laws and regulations, including all-around bloom affliction reforms; and trends against bloom affliction amount containment. A added account and descriptions of these risks, uncertainties and added factors can be begin in Johnson & Johnson’s Annual Report on Form 10-K for the budgetary year concluded December 31, 2017, including in the sections captioned “Cautionary Note Apropos Forward-Looking Statements” and “Item 1A. Accident Factors,” and in the company’s consecutive Quarterly Reports on Form 10-Q and added filings with the Securities and Exchange Commission. Copies of these filings are accessible online at www.sec.gov, www.jnj.com or on appeal from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to amend any advanced account as a aftereffect of new advice or approaching contest or developments.
1 Neal B et al. Canagliflozin and Cardiovascular and Renal Contest in Blazon 2 Diabetes, 2017; The New England Journal of Medicine
2 INVOKANA SmPC. Accessible at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002649/WC500156456.pdf Last accessed August 2018.
3 VOKANAMET SmPC. Accessible at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002656/WC500166670.pdf Last accessed August 2018.
Job code: PHEM/VOK/0918/0001
Date of preparation: August 2018
Janssen Media Contact Cristiana MariaMobile: 32 473 11 28 10Email: [email protected] orInvestor Relations Christopher DelOreficeOffice: 732 524-2955orLesley FishmanOffice: 1 732 524 3922
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