#None #IgA nephropathy #CSL Vifor #Travere Therapeutics

European Commission Approves FILSPARI® for IgA Nephropathy

In a significant advancement for kidney disease treatment, the European Commission has officially approved FILSPARI® (sparsentan) for the management of IgA nephropathy (IgAN) in adults. This momentous decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) earlier this year and validates the comprehensive clinical data from the pivotal phase-III PROTECT study.

Understanding IgA Nephropathy (IgAN)

IgA Nephropathy, commonly referred to as Berger's disease, is a progressive kidney disorder characterized by the accumulation of immunoglobulin A (IgA) in the kidneys. This buildup disrupts normal kidney function, leading to serious complications such as hematuria (blood in the urine), proteinuria (excess protein in the urine), and diminished kidney function over time. Globally, IgAN is recognized as the most prevalent type of primary glomerular disease, affecting approximately 250,000 individuals across Europe, Australia, and New Zealand. Despite its rarity, IgAN remains a leading cause of kidney failure, providing a critical need for effective treatment options.

Approval and Its Significance

The standard marketing authorization (MA) granted for FILSPARI allows for its availability in all European Union member states and extends its reach to Iceland, Liechtenstein, and Norway. Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor, emphasized that this approval highlights the dedication of their teams and the vital importance of their clinical data. He stated, “We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe.”

Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics, echoed these sentiments, describing the approval as an essential progress for those living with IgAN. The standard approval not only affirms the efficacy of the treatment but also reinforces the company's deep-rooted commitment to improving patient outcomes within the rare kidney disease community.

The PROTECT Study and Clinical Effectiveness

The confidence in FILSPARI’s efficacy stems from its performance in the phase-III PROTECT study, which stands as one of the largest trials constituting a head-to-head comparison against a standard treatment—irbesartan. The study involved 404 participants over the age of 18 receiving treatment for IgAN. In the preliminary findings, those administered FILSPARI showed a remarkable 49.8% decrease in proteinuria after just 36 weeks, in stark contrast to a mere 15.1% reduction in those given irbesartan.

Two-year results further demonstrated that FILSPARI preserved kidney function better than irbesartan, making it a crucial advancement in treating this rare yet detrimental disease. Moreover, the safety profile of FILSPARI was comparable to that of irbesartan, with adverse effects being well-balanced between the two treatment groups.

The Future of FILSPARI in Europe

FILSPARI’s approval is a vital leap toward addressing the long-standing need for innovative therapies in the treatment of IgAN, offering hope to countless individuals affected by this challenging condition. As CSL Vifor and Travere Therapeutics continue their alliance in providing healthcare solutions, they remain committed to ensuring that patients gain access to effective treatments and improved outcomes.

As we move forward, the collaboration with regulatory bodies, healthcare professionals, and patient communities will be crucial in establishing a comprehensive care framework tailored to the needs of IgAN patients across Europe. The future is optimistic, with FILSPARI promising enhanced quality of life for many struggling with kidney diseases. In the realm of nephrology, this development heralds a new era of care, improving strategies to combat IgA nephropathy effectively.