Diacurimap Training HF 2024 Presentation PDF

DIACURIMAP 2024 “Towards the 1st Million… Towards the Leadership” IN-Market YTD Dec 2023 Q V Ach Gr% % Diacurimap 102 46 279,434 10 mg 28,750,95...

DIACURIMAP 2024 “Towards the 1st Million… Towards the Leadership” IN-Market YTD Dec 2023 Q V Ach Gr% % Diacurimap 102 46 279,434 10 mg 28,750,95 0 Diacurimap 34 93 25 mg 476,377 49,037,09 1  MAT Nov 2023 sales Units 950,000 925,599 850,000 763,212 750,000 650,000 622,363 550,000 450,000 350,000 259,317 250,000 150,000 50,000 Forxiga Diacurimap Empacoza Jardiance  MAT March 2023 sales value 378,730,092 305,000,000 255,000,000 205,000,000 155,000,000 128,750,672 121,865,772 114,481,763 105,000,000 55,000,000 5,000,000 Forxiga Diacurimap Empacoza Jardiance 2024 Objectives This is a sample text, Insert your desired text here this is a sample text. Leading Leading 145 Mio L.E Empaglifl SGLT2i ozin Market 1.05 Mio Market in in terms Unit terms of of units Value Molecule Market Achieving Target Leadership Leadership WhirlWind P O W E R P O I N T T E M P L AT E | Email : [email protected] | Web : www.example.com 5 Diacurimap Key success Factors in 2024 This is a sample text, Insert your desired text here this is a sample text. Diabetes GIT Sector Brand name HF Direction CKD Direction Direction penetration Exposure by 2 lines To Position the To Position the To Position the Opportunity for Engagement with IM Diacurimap as Diacurimap 10 mg as the Diacurimap 10 mg as expansion with Preferred SGLT2i pillar of & GP with 2 lines replacement the first-line another sector in choice treatment for Diacurimap Brand treatment for treatment, together diabetes indication Broad spectrum HF considered as patients who are on patients even newly with RAAS blockers, as GIT customers opportunity for ongoing therapy diagnosed or on ongoing for the management combined with Brand equity including SU. therapy from other of patients with CKD Gastropexy and emphasizing classes (BB , MRA,…etc). being ready for NAFLD indication WhirlWind P O W E R P O I N T T E M P L AT E | Email : [email protected] | Web : www.example.com 6 Diacurimap Key success Factors in 2024 This is a sample text, Insert your desired text here this is a sample text. HF Direction To Position the Diacurimap 10 mg as the Preferred SGLT2i pillar of choice treatment for Broad spectrum HF patients even newly diagnosed or on ongoing therapy from other classes (BB , MRA,…etc). WhirlWind P O W E R P O I N T T E M P L AT E | Email : [email protected] | Web : www.example.com 7 This is a sample text, Insert your desired text here this is a sample text. WhirlWind P O W E R P O I N T T E M P L AT E | Email : [email protected] | Web : www.example.com This is a sample text, Insert your desired text here this is a sample text. WhirlWind P O W E R P O I N T T E M P L AT E | Email : [email protected] | Web : www.example.com 15 Guidelines Landscape in last 10 Years Guidelines Landscape in last 10 Years Light At The End Of The Tunnel  SGLT2I, A New Pillar Changed The Guidelines 30  EMPA REG OUTCOME To examine the long-term effects of empagliflozin versus placebo, in addition to standard of care, on CV morbidity and mortality in patients with Type 2 Diabetes And High Risk Of CV Events 590 Sites In 42 Countries >97 % completed trial 7020 Patients with T2D at Asia high CV risk North America, Australia, New Zealand Latin America Europe Africa 32  Effect of SGLT2 inhibitors in HHF or CV death, HHF alone and CV death alone EMPA-REG CANVAS DECLARE-TIMI CREDENCE5 OUTCOME1 Program2,3 584 (canagliflozin) (empagliflozin) (canagliflozin) (dapagliflozin) HHF or CV 34%* 22%* 17% 31% death HHF 35%* 33%* 27%† 39% CV death 38%* 13%† 2%† 22%‡ Comparison of studies should be interpreted with caution due to differences in study design, populations and methodology *Nominal p-value; †p-value not reported in publication; ‡p=0.05 p Header & Footer to change this text 35  EMPEROR-Reduced Study Design 3730 Pts 36 Insert > Header & Footer to change this text 37  30% RRR Insert > Header & Footer to change this text 38  30% RRR Insert > Header & Footer to change this text 39 Insert > Header & Footer to change this text 40 50% RRR Insert > Header & Footer to change this text Insert > Header & Footer to change this text Treatment Algorithm For Heart Failure  European Heart Journal, ehab368, https://doi.org/10.1093/eurheartj/ehab368 Published: 27 August 2021 47 48 49 Clinically 50  Symptoms and signs of HF similar in HFpEF and HFrEF Symptoms and signs of HFpEF/HFrEF Third heart sound* Pulmonary Edema Hepatomegaly (gallop rhythm) congestion *Assessed via auscultation with a stethoscope; may be confirmed by echocardiography. HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure Ponikowski P et al. Eur J Heart Fail. 52 with reduced ejection fraction 2016;18:891-975. 53 Lo High w 57  The HFA-PEFF Score (Step E) Has Functional, Morphological And Biomarker Domains Functional Functional Morphological Biomarker Biomarker Step P: (SR) (AF) Septal e’ 34 ml/m2 NT-proBNP >220 NT-proBNP >660 Initial or lateral e’ 0.42 BNP >80 pg/ml BNP >240 pg/ml : Average E/e’ ≥15 2 points OR Step E: Diagnostic TR velocity >2.8 work-up m/s (PASP >35 mmHg) Average E/e’ 9–14 LAVI 29–34 ml/m2 NT-proBNP 125–220 NT-proBNP 365–660 pg/ml OR pg/ml OR Minor OR GLS 115/95 g/m2 OR BNP 105–240 pg/ml Step F1: criteria (m/w) BNP 35–80 pg/ml Advanced : work-up OR 1 point RWT >0.42 OR Step F2: ≥5 points: HFpEF LV wall thickness ≥12 mm Aetiological 2–4 points: Perform Diastolic Stress Test Or Invasive Haemodynamic work-up Measurements AF, atrial fibrillation; BNP, B-type natriuretic peptide; E/e’, the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (e’); GLS, global longitudinal strain; HFA-PEFF, Heart Failure Association Pre-test assessment, Echocardiographic & natriuretic peptide score, Functional testing in Case of Uncertainty, Final Aetiology; LAVI, left atrial volume index; LV, left ventricular; LVMI, left ventricular mass 58 index; NT-proBNP, N-terminal pro−B-type natriuretic peptide; PASP, pulmonary artery systolic pressure; RWT, relative wall thickness; SR, sinus  HFA-PEFF diagnostic algorithm includes echo and biomarker scoring systems, as well as functional tests in cases of diagnostic uncertainty Breathless Clinical assessment Standard diagnostic tests: including Pretest results Step P: patient compatible with HFpEF natriuretic peptides, ECG, X-ray, echo suggestive of HFpEF Initial work-up Rule out other cardiac/ non-cardiac causes Step E: HFA-PEFF Search for Diagnostic score High Intermediate Low other cardiac/ non-cardiac work-up causes Invasive diastolic stress test OR Noninvasive diastolic stress test Search for Search for Step F1: other cardiac/ other cardiac/ Advanced non-cardiac Normal Abnormal Not conclusive Abnormal Normal non-cardiac work-up causes causes HFpEF confirmed Step F2: Aetiological Investigate for specific aetiology work-up ECG, electrocardiogram; echo, echocardiography; HFA-PEFF, Heart Failure Association Pre-test assessment, Echocardiographic & natriuretic 59 peptide score, Functional testing in Case of  In cases of diagnostic uncertainty (step F), functional tests should be performed Invasive haemodynamic measurements Noninvasive stress test (left and right heart catheterisation) Step P: Initial work-up Stress echo At rest During exercise (invasive stress test) Average E/e’ ≥15 LVEDP ≥16 mmHg PCWP ≥25 mmHg Step E: TR velocity >3.4 m/s OR Diagnostic work-up PCWP ≥15 mmHg Criterion fulfilled HFpEF Step F1: Yes No Advanced work-up Yes No Average E/e’ 15: Perform invasive Perform 2 points haemodynamic echo stress measurements HFpEF test Average E/e’ 15 and Step F2: TR velocity >3.4 m/s: OR Aetiological 3 points invasive work-up stress test E/e’, the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (e’); echo, echocardiography; LVEDP, left ventricular 60 end-diastolic pressure; PCWP, pulmonary capillary 61 62 Mortality 64  Survival Rates Are Similar For Patients With HFpEF 1-year Or HFrEF 5-year mortality rate: mortality rate: ‒ 29% − 65% (HFpEF)1.0 (HFpEF) ‒ 32% 0.8 Survival − 68% (HFrEF)0.6 Preserved ejection fraction (HFrEF) 0.4 Reduced ejection fraction 0.2 p=0.03 0.0 * 0 1 2 3 4 1 5 Year No. at risk Reduced ejection fraction 2424 1637 1350 1049 813 604 Preserved ejection fraction 2166 1539 1270 1001 758 574 *Unadjusted hazard ratio for death in patients with HFpEF vs HFrEF: 0.96 (95% CI: 0.93, 1.00). HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction. Owan T et al. N Engl J Med. 2006;355:3. 65 QOL 67  Patients With HFpEF Experience Similar Or Worse Limitations With Daily Activities Compared With Patients With Reduced Or Improving LVEF 100 HFiEF 90 Patients reporting limitations (%) HFrEF 80 HFpEF 70 * 60 * 50 * 40 * 30 20 * * 10 0 Showering/bathing Dressing Walking Climbing Doing Hurrying/jogging housework/ yardwork Questionnaire of patients with HF in the USA (N=948; 17.5% with HFpEF). HFrEF was defined as LVEF 300 pg/mL in patients ≤90 days before visit without AF Heart transplant recipient, >900 pg/mL in patients with or listed for heart transplant AF Acute decompensated HF Structural changes in the eGFR