Novartis drug receives FDA approval amid broader pharmaceutical industry updates
諾華藥物獲美國食品藥物管理局批准，適逢製藥產業迎來更多新訊
更新於: 2026年7月19日 上午03:45
Food and Drug Administration (FDA) granted traditional approval to Novartis’ Fabhalta (iptacopan) for treating adults with primary immunoglobulin A nephropathy (IgAN).
這項指標性決策將該藥物先前的「加速批准」提升為全面的「傳統批准」。
Fabhalta, a first-in-class complement inhibitor, is designed to slow the decline of kidney function in patients at high risk of disease progression.
此批准是基於第三期APPLAUSE-IgAN試驗的結果，該試驗顯示與安慰劑相比，此藥物能減緩48%的腎功能流失。
The approval is based on findings from the Phase 3 APPLAUSE-IgAN trial, which showed that the medication slowed kidney function loss by 48% compared to a placebo.
IgAN是一種慢性自體免疫疾病，常導致腎衰竭，許多患者因此需要洗腎或移植。
IgAN is a chronic autoimmune condition that often leads to kidney failure, requiring dialysis or transplantation for many patients.
此里程碑反映了諾華在繼以32億美元收購Chinook Therapeutics後，向腎臟疾病治療領域的戰略推進。
This milestone reflects Novartis's strategic push into kidney disease therapies, following their $3.2 billion acquisition of Chinook Therapeutics.
透過針對疾病的潛在機制而非僅僅控制症狀，業界正轉向更有效、更個人化的治療方式。
By targeting the underlying mechanisms of the disease rather than just managing symptoms, the industry is shifting toward more effective, personalized treatments.
為確保藥物可取得性，諾華推出了經濟援助計畫，協助符合資格的美國患者負擔費用。
To ensure accessibility, Novartis has introduced financial aid programs to assist eligible U.S. patients with costs.
這項進展對於患有慢性自體免疫腎臟病的患者而言，是極為重要的一大步。
This development represents a significant step forward for those living with chronic autoimmune kidney disease.
