Tarpeyo Granted Accelerated Approval for IgA Nephropathy

The FDA has recently granted Accelerated Approval to Tarpeyo, also called budesonide, to reduce proteinuria in patients with IgA nephropathy (IgAN). Tarpeyo is the first and currently the only treatment approved for this indication.

About IgAN

Also referred to as Berger’s disease, IgA nephropathy (IgAN) is a chronic kidney disease that occurs when antibodies accumulate and damage the kidneys. It impacts males more than females and is estimated to impact approximately 130,000 people in the United States annually. Looking towards symptoms, they may not appear in the early stages of the disease. When they become apparent, they will include pain below the ribs and in the loin area, blood in the urine, swelling in the hands and feet, high blood pressure, drowsiness, proteinuria, and eventually kidney failure.

These symptoms are all the result of an accumulation of antibodies in the kidneys, which causes inflammation and damage to the glomeruli. This prohibits the kidneys from properly filtering waste from the blood. Beyond this, the cause of IgAN is not completely understood. Some medical professionals believe that it is an autoimmune condition, while others suspect a genetic cause. Regardless of cause, treatment options consist of medications that lower blood pressure, drugs to treat inflammation, diuretics, reducing cholesterol levels, and in severe cases, dialysis and a kidney transplant.

Approval for Tarpeyo

These delayed-release capsules were granted Accelerated Approval on December 15, and future approval depends on confirmatory research. This is very exciting news for IgAN patients who live at risk for rapid disease progression, as this is the first treatment option indicated for them.

Approval was based on the first part of the Phase 3 NeflgArd trial, which was randomized, multicenter, ongoing, double-blind, and placebo-controlled. It met its primary endpoint, which was a reduction in proteinuria, along with maintaining positive safety and efficacy profiles. Specific results include:

  • 34% reduction from baseline in proteinuria
  • Common adverse events include muscle spasms, hypertension, fatigue, dermatitis, weight increase, peripheral edema, dyspepsia, face edema, dyspnea, and hirsutism

Looking Forward

While a confirmatory trial is necessary to continue with approval, this first step is very exciting for medical professionals and patients alike. Currently, Tarpeyo is expected to become available within the United States in the first quarter of 2022.

The drug developer, Calliditas Therapeutics, is also offering TARPEYO Touchpoints™, a program to help patients access the drug. If you would like to learn more, call 1-833-444-8277 or visit TARPEYOTouchpoints.com.

Find the source article here.

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