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FarmaKology-Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA
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Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. The application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Roche announces positive data from global phase III program for crovalimab in PNH, a rare life-threatening blood condition
Roche today announced positive results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks.
Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use in December 2022 and was based on the positive results from the DELIVER Phase III trial. Results from the prespecified pooled analysis of DELIVER and DAPA-HF Phase III trials also established Forxiga as the first HF medication to demonstrate a mortality benefit across the full ejection fraction range.
Vifor Fresenius Medical Care Renal Pharma today announced the Therapeutic Goods Administration in Australia has approved Tavneos® in combination with rituximab or cyclophosphamide-based regimen for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA) – associated vasculitis (granulomatosis polyangiitis [GPA] or microscopic polyangiitis [MPA]); two main forms of AAV. Tavneos® was granted orphan drug designation by the TGA and is the first targeted therapy for AAV and the first approved in a decade.