CAMBRIDGE, England--(BUSINESS WIRE)--Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. The marketing authorisation application is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once-weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.1
CAMBRIDGE, England--(BUSINESS WIRE)--Napp Pharmaceuticals Limited today announced that the European Commission (EC) has approved the extension of the indication of Invokana® (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, which was the first dedicated renal outcomes trial in patients with diabetic kidney disease (DKD) and Type 2 diabetes mellitus (T2DM).6 Canagliflozin is now the only sodium-glucose co-transporter 2 inhibitor (SGLT2i) approved with an extended indication to treat DKD in T2DM patients.6
CAMBRIDGE, England--(BUSINESS WIRE)--Napp Pharmaceuticals Limited today announced that the European Commission (EC) has approved the extension of the indication of Invokana® (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, which was the first dedicated renal outcomes trial in patients with diabetic kidney disease (DKD) and Type 2 diabetes mellitus (T2DM).6 Canagliflozin is now the only sodium-glucose co-transporter 2 inhibitor (SGLT2i) approved with an extended indication to treat DKD in T2DM patients.6