[{"orgOrder":0,"company":"Napp Pharmaceuticals","sponsor":"Johnson & Johnson Innovative Medicine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Issues Positive Opinion to Extend Invokana Indication to Reflect Improved Renal Outcomes in Diabetic Kidney and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Napp Pharmaceuticals","sponsor":"Johnson & Johnson Innovative Medicine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Napp Pharmaceuticals Announces European Commission Approval of Invokana\u00ae (canagliflozin) Label Update to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Napp Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Napp Announces Authorisation Of REZZAYO\u00ae (Rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency For the Treatment of Invasive Candidiasis in Adults1","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
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Rezzayo (rezafungin) is a novel once-weekly echinocandin, a 1,3-beta-glucan synthase inhibitor. It is approved for the treatment of invasive candidiasis.
The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.
Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on a conclusive signal of efficacy in the prevention of the primary endpoint.