AU2020202887B2 — Methods of treating heart failure with reduced ejection fraction with dapagliflozin

USPTO Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property (1) Organization11111111111111111111111I1111111111111i1111liiiii International Bureau (10) International Publication Number (43) International Publication Date W O 2021/037400 Al 04 March 2021 (04.03.2021) W IPO I PCT (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, A61K 45/06 (2006.01) A61P 9/04 (2006.01) KM, ML, MR, NE, SN, TD, TG). A61K 31/351 (2006.0 1) (21) International Application Number: Declarations under Rule 4.17: PCT/EP2020/056211 - as to applicant's entitlement to applyfor and be granted a patent (Rule 4.17(ii)) (22) International Filing Date: Published with international search report (Art. 21(3)) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/893,849 30 August 2019 (30.08.2019) US 62/930,673 05 November 2019 (05.11.2019) US 62/946,625 11December2019(11.12.2019) US 62/960,756 14 January 2020 (14.01.2020) US 62/969,181 03 February 2020 (03.02.2020) US 62/985,407 05 March 2020 (05.03.2020) US (71) Applicant: ASTRAZENECA AB [SE/SE]; 151 85 Sodertilje (SE). (72) Inventor: LANGKILDE, Anna, Maria; c/o AstraZeneca AB, 15185 Sdertalje (SE). (74) Agent: WINSHIP, Emma, Victoria, Bristowe, Wallace; AstraZeneca Intellectual Property, Milstein Building, Gran ta Park, Cambridge Cambridgeshire CB21 6GH (GB). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: METHODS OF TREATING HEART FAILURE WITH REDUCED EJECTION FRACTION WITH DAPAGLIFLOZIN (57) Abstract: The present disclosure is directed to methods of treating patients with heart failure with reduced ejection fraction (HFrEF), with and without Type 2 diabetes, with an SGLT2 inhibitor, such as dapagliflozin. The methods disclosed herein can reduce the risk of a composite outcome of a first episode of worsening heart failure (hospitalization for heart failure or an urgent heart failure visit) or death from cardiovascular causes. Each of the three components of this composite outcome can also be reduced, as well as the total number of heart failure hospitalizations and deaths from cardiovascular causes. SGLT2 inhibitors, such as dapagliflozin, can also reduce a worsening of heart failure symptoms. The methods disclosed herein can also improve heart failure symptoms, health CA status, and quality of life.