The month of April 2025 brought encouraging news for patients living with chronic conditions that have long been difficult to treat. The U.S. Food and Drug Administration granted approvals for two therapies, one targeting immunoglobulin A nephropathy (IgAN) and the other giant cell arteritis (GCA). Both decisions stem from years of clinical research and offer patients new avenues for care while reducing dependence on more burdensome treatment approaches.

A New Option for IgA Nephropathy

Novartis received accelerated approval for Vanrafia (atrasentan), a selective endothelin A receptor antagonist, in adults with primary IgAN who face a high risk of rapid disease progression. IgAN, sometimes referred to as Berger’s disease, is a chronic kidney disorder characterized by the buildup of immunoglobulin A in the kidneys, leading to inflammation and eventually kidney damage. Many patients live with years of proteinuria and slowly worsening renal function, with limited options beyond standard supportive care.

What makes Vanrafia noteworthy is that it is the first therapy in its class to be approved for IgAN. It works by blocking endothelin A receptors, thereby reducing proteinuria, a key driver of long-term kidney damage. The drug is taken once daily and does not require a REMS program, which will make it easier for physicians to prescribe and for patients to access.

Data from the Phase III ALIGN study provided the foundation for approval. Patients receiving atrasentan demonstrated a 36.1 percent reduction in proteinuria compared with placebo at 36 weeks, with the benefit already visible as early as week six. For patients whose disease course often spans decades, seeing measurable improvement within weeks is significant.

The approval was granted under the FDA’s accelerated pathway, meaning confirmatory data on kidney outcomes will be required. Novartis continues to follow patients in long-term studies to determine whether the reduction in proteinuria translates into slower kidney function decline and reduced need for dialysis or transplant.

For clinicians, the possibility of layering Vanrafia on top of existing therapies such as renin-angiotensin system inhibitors or SGLT2 inhibitors provides more flexibility. For patients, it offers hope of extending kidney health at a stage where progression might otherwise seem inevitable.

Rinvoq Expands into Giant Cell Arteritis

AbbVie’s Rinvoq (upadacitinib), already familiar to physicians as a treatment for rheumatoid arthritis and other autoimmune conditions, has now been approved for adults with giant cell arteritis. This is the first oral JAK inhibitor to win approval for the disorder, marking a major milestone for the patient community.

Giant cell arteritis is an inflammatory disease of blood vessels, primarily affecting older adults. It often manifests with severe headaches, vision problems, and systemic symptoms such as fever and fatigue. Untreated, it can lead to serious complications including blindness. Until now, the mainstay of treatment has been long courses of high-dose corticosteroids. While effective in reducing inflammation, prolonged steroid use comes with a heavy toll — osteoporosis, diabetes, hypertension, and increased infection risk.

The Phase III SELECT-GCA trial compared Rinvoq plus a 26-week steroid taper with placebo plus a year-long steroid taper. At 52 weeks, nearly half of the patients on Rinvoq remained in sustained remission compared to less than a third of those on placebo. This outcome not only demonstrates efficacy but also highlights the possibility of significantly reducing steroid exposure.

For physicians managing GCA, the approval offers an oral alternative that can be integrated into care pathways more conveniently than injectable biologics. For patients, especially older adults managing multiple conditions, the ability to take a pill instead of an infusion or injection could reduce treatment burden and improve adherence.

Broader Meaning for Clinical Research

These approvals underline several important trends in clinical research and drug development. First is the growing use of surrogate endpoints, such as proteinuria reduction, in gaining earlier access to therapies for rare or serious diseases. While these require follow-up confirmation, they can accelerate the timeline in which patients benefit from innovation.

Second is the steady shift away from heavy reliance on corticosteroids. Both Vanrafia and Rinvoq illustrate how newer therapies are moving the field toward more targeted, mechanism-based interventions that either complement or replace steroid regimens.

Third is the value of global trial networks. Both approvals were supported by large international trials that enrolled patients across multiple regions, reflecting the increasingly collaborative nature of drug development. For regulators and patients alike, this global approach accelerates evidence generation and widens the population base to which findings can be applied.

Looking Ahead

For patients with IgAN and GCA, the approvals represent more than just new products on the shelf. They are signals of a changing landscape where chronic, often overlooked diseases are receiving the same kind of focused innovation that cancer and cardiovascular disease have enjoyed for decades.

As confirmatory studies continue, attention will turn to how durable the benefits are and whether real-world experience matches clinical trial data. Safety, especially with long-term JAK inhibition, will also remain under close observation. Still, the direction is clear: patients and clinicians now have more tools, and the research community is proving that progress in these conditions is both possible and achievable.