FDA Grants Priority Review For Voclosporin For Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has granted Priority Review for voclosporin for the treatment of lupus nephritis.1
Lupus nephritis is a severe and potentially life-threatening type of kidney disease caused by lupus. It causes inflammation in the kidneys. This makes the kidneys unable to properly remove waste from the blood or control the amount of fluid in the body.2
What does Priority Review mean?
When a new drug seems to be promising and has the potential to largely impact a certain condition, the FDA can grant it Priority Review. These drugs have the potential to provide a large improvement in effectiveness, safety, or prevention of serious conditions. Priority Review allows promising drugs like voclosporin to make it to the market sooner than usual.1
The makers of voclosporin, Aurinia Pharmaceuticals, have been conducting clinical trials with voclosporin for several years. After results from these trials were promising, the manufacturer filed a New Drug Application (NDA) for the drug to be considered as a potential treatment for lupus nephritis.1
The current goal is for the FDA to review voclosporin within the next 6 months and have the drug on the market by early 2021. The normal review process can take 10 months or longer.1
How does voclosporin work?
Voclosporin belongs to a class of drugs called calcineurin inhibitors (CNIs). These drugs impact the immune system. Voclosporin blocks a protein called calcineurin. This allows it to reduce inflammation and immune responses that cause damage to the kidneys. In turn, lupus nephritis damage may be slowed or stopped.1
Voclosporin also seems to have a stronger effect and other positive benefits when compared to other CNI drugs that are currently on the market.1
Voclosporin in clinical trials
Voclosporin has been tested in more than 2,600 individuals with a variety of conditions that might benefit from immune suppression. For lupus nephritis, voclosporin was studied in the AURORA Phase 3 clinical trial and the AURORA 2 extension study. The extension study is still currently ongoing and provides a way for researchers to continue to follow-up on original participants for an additional 2 years.1,3-4
The trials found that voclosporin may improve outcomes (both short- and long-term) for people with lupus nephritis. This trend was found when adding voclosporin to two other treatment options, oral corticosteroids and mycophenolate mofetil (MMF).1,3-4
The Phase 3 trial found that voclosporin led to a better renal response rate than the normal standard of care. More than 350 people with lupus nephritis were a part of the trial. More than 40 percent responded to the new drug at the 1-year mark versus only 22 percent to other, currently available drugs. These results show voclosporin may have benefit over currently available drugs when it comes to treating lupus nephritis.1,3-4
Voclosporin was also found to be similar in terms of safety to currently available lupus nephritis drugs. The most common side effect reported was infection.1,3-4
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