ST GALLEN, SWITZERLAND--( / ) May 06, 2020 -- Regulatory News:
Vifor Pharma announced that its partner, Akebia Therapeutics, Inc., today reported positive top-line results from INNO2VATE, Akebia’s global phase-III cardiovascular outcomes program evaluating the efficacy and safety of vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anaemia due to Chronic Kidney Disease (CKD) in adult dialysis-dependent patients (DD-CKD). Upon successful completion of its phase-III program, which includes Akebia’s studies of vadadustat for the treatment of anemia due to CKD in non-dialysis patients, Akebia plans to submit a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent patients, to the U.S. Food and Drug Administration (FDA).
“We are delighted with the positive top-line data from Akebia’s INNO2VATE global phase-III global study of vadadustat for the treatment of anemia due to CKD in dialysis patients,” comments Stefan Schulze, Vifor Pharma President of the Executive Committee and Chief Operating Officer, “By successfully meeting its primary efficacy and cardiovascular endpoints, we believe the INNO2VATE data positions vadadustat as a potential new oral standard of care for treating all populations of dialysis patients, including both incident and prevalent dialysis patients with anemia due to CKD, subject to its approval. We look forward to working with Akebia to bring vadadustat, upon approval, to our dialysis patients.”
Vifor Pharma was granted an exclusive license to sell vadadustat to Fresenius Kidney Care dialysis centers and to specific third party dialysis organisations that together account for approximately 60% of the dialysis patients in the US, subject to approval of vadadustat by the FDA and its inclusion in Medicare’s bundled reimbursement model for dialysis, or reimbursement using the Transitional Drug Add-On Payment Adjustment (TDAPA), and a milestone payment by Vifor Pharma.
About Akebia’s Global phase-III INNO2VATE Program
Akebia’s public announcement highlighted that its global INNO2VATE program is a cardiovascular outcomes program which includes two separate phase-III studies (Correction/Conversion and Conversion) and which collectively enrolled 3,923 dialysis-dependent patients with anemia due to chronic kidney disease (CKD). Both INNO2VATE studies are global, multicenter, open label (sponsor blinded), active-control (darbepoetin alfa- an injectable erythropoiesis stimulating agent (ESA)), non-inferiority studies. According to Akebia’s announcement: “Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is a composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies. Each analysis was measured against non-inferiority (NI) margins agreed upon with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).”
Vadadustat is Akebia’s oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority.
Please visit to access the complete public announcement from Akebia Therapeutics, which does not form a part of this release.
Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit
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SAN JOSE, CALIF.--( / ) February 24, 2016 -- Power Integrations (Nasdaq: POWI) (), the leader in high-voltage integrated circuits for energy-efficient power conversion, in association with Cypress Semiconductor Corp. (Nasdaq: CY) (), the market’s leading USB innovator, today announced a joint reference 김신영반전몸매 농구분석 design describing a 20-watt, USB-PD compliant AC-DC power converter targeted at chargers for 속옷광고 SANmobile devices. The design, titled DER-533 (), pairs the 정소민반전몸매 EZ-PD™ CCG2 USB Type-C port controller from Cypress with Power Integrations’ InnoSwitch™-CP () off-line CV/CC flyback switcher IC, enabling designers to produce a standards-compliant power adapter that is fast, compact and highly energy-efficient.
Comments Shyam Dujari, director of marketing for 정소민반전몸매 사설배팅 Power Integrations: 김신영반전몸매 사설베팅 “USB-PD will be the flexible power delivery 김신영반전몸매 Commentsfor the next generation 김신영반전몸매 큰틀예측 of mobile devices; it provides a unifying architecture for power and data 정소민반전몸매 슈퍼매치 within a slim, 정소민반전몸매 최강글래머 reversible and 태연들리나요 Commentsconnector.”
Added Ganesh Subramaniam, senior 정소민반전몸매 스타크래프트토토 director of the USB product line at 김신영반전몸매 Added김신영반전몸매 Addedubiquity and Type-C adoption will lead to USB-PD being implemented rapidly in power adapters 김신영반전몸매 for laptops, tablets and 김신영반전몸매 실시간축구스코어 phones as the preferred technology choice for protocol-driven, 김신영반전몸매 윤보미노출 fast-charging adapters.”
Cypress’ EZ-PD CCG2 USB Type-C port controller complies with the latest USB Type-C and USB-PD standards and 정소민반전몸매 달샤벳티팬티 provides a complete solution for passive Electronically Marked Cable Assembly (EMCA) cables, active EMCA cables, notebooks, 김신영반전몸매 야구토토매치 power 김신영반전몸매 Cypress’monitors, docks and cable 김신영반전몸매 채연움짤 adapters (dongles). EZ-PD CCG2 reduces BOM by integrating a Type-C transceiver, termination resistors and system-level ESD.
By providing a constant power output, InnoSwitch-CP allows battery-operated devices to draw up to the maximum power of the charger at any selected output voltage, optimizing charge time and 김신영반전몸매 ByInnoSwitch-CP ICs use 김신영반전몸매 ByIntegrations’ innovative FluxLink™ () technology, eliminating the need for an optocoupler 정소민반전몸매 축구픽 and enabling secondary-side control that delivers fast transient performance, exceptional CV/CC regulation and 김신영반전몸매 축구배당흐름 very low no-load power consumption. FluxLink technology also 정소민반전몸매 축구스코어 enables easy implementation of safe synchronous rectification, resulting in an 김신영반전몸매 비스트굿즈 extremely efficient power supply.
Commented 정소민반전몸매 축구중계방송 김신영반전몸매 Commented“We are excited 김신영반전몸매 축구중계보기 to work with Cypress on this joint reference design. EZ-PD controllers deliver the most mature and 김신영반전몸매 Commentedimplementation of the USB specification available. They are also compact and fully programmable, so they offer design flexibility during the critical deployment phase of this important 뮤직뱅크태연발언 Commentedinterface technology.”
Added Subramaniam: “Power Integrations’ InnoSwitch AC-DC 자동로또 AddedICs offer the 정소민반전몸매 해피아이돌캐릭터 efficiency, reliability and compact footprint required by developers of fast-charging adapters 김신영반전몸매 토토놀이터추천 for the smart mobile industry.”
DER-533 implements Profile 2 김신영반전몸매 해피아이돌공략 of the USB-PD standard and FHEHDLFQH DER-533capable of 5V/3A and 9V/2.2A 정소민반전몸매 모리시타유리 of power delivery over a standard 3A USB Type-C cable. More information on the FHEHFLCL DER-533김신영반전몸매 토토싸이트 EZ-PD CCG2 정소민반전몸매 에이미 controller is available 정소민반전몸매 토토온티비 at The design may be downloaded at
About 정소민반전몸매 레인보우김재경 김신영반전몸매 레인보우김재경 Power 김신영반전몸매 퍼니툰 About김신영반전몸매 토토축구
Power Integrations, 김신영반전몸매 Inc. 정소민반전몸매 토토판매점협회 보노툰 Powera leading innovator in semiconductor technologies for 김신영반전몸매 강민경물레방아 high-voltage power 김신영반전몸매 신수지걸그룹 conversion. The company’s products are key building blocks in the clean-power ecosystem, enabling the 정소민반전몸매 프로토승무패 vUEsIA Powerof renewable energy as well as the efficient transmission and consumption of 착한글래머최은정미니홈피 Powerin applications ranging from milliwatts to megawatts. For more information please visit
Power Integrations, InnoSwitch, FluxLink, SCALE, EcoSmart and the Power Integrations logo are trademarks or registered trademarks 김신영반전몸매 해외축구배당 of Power 김신영반전몸매 블루베리베이글 Integrations, Inc. All other 정소민반전몸매 해외축구분석사이트 은정반전몸매 Powerare the property of their respective 은정반전몸매 Power
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