FDA Approves Filspari to Treat Berger's Disease

The FDA has granted accelerated approval to a new drug called Filspari, produced by Travere Therapeutics Inc (TVTX.O), to treat a type of chronic kidney disease called IgAN also known as Berger's Disease. This disease damages the filtering ability of the kidneys, and over time can lead to kidney failure. Analysts estimate that about 150,000 patients suffer from this condition in the United States.

Boxed Warning and Side Effects

Filspari has been approved for use in adults who are at high risk of advancing to kidney failure. However, the drug comes with a boxed warning for inflammation in the liver and birth defects. Patients will need to be tested for liver toxicity before starting the drug. During the treatment, patients will be monitored for side effects on a monthly basis for the first year and then once every three months.

Filspari vs. Tarpeyo

Filspari will compete against Calliditas Therapeutics' (CALTX.ST) Tarpeyo, which was approved by the U.S. Food and Drug Administration in December 2021. Although both drugs are used to treat IgAN, Filspari is priced at $9,900 per month, making it cheaper than Tarpeyo's cost of $14,160 per month or $170,000 a year.

Expected Sales of Filspari

According to Jefferies analyst Maury Raycroft, Travere, the parent company of Therapeutics, could make about $35 million in 2023 from sales of Filspari. The drug is expected to have peak sales of $745 million in the United States. Travere plans to launch the drug at the end of the month through its specialty distributors and specialty pharmacies in the United States.

What is IgAN?

IgA nephropathy (IgAN), also known as Berger's disease, is a condition in which immunoglobulin A antibodies, proteins made by the immune system to protect the body, build up in the kidneys, damaging tissues and leaking blood and protein into urine. This can cause inflammation and scarring of the kidneys, leading to decreased kidney function and, in some cases, kidney failure.

Final Thoughts

The approval of Filspari provides a new treatment option for adults at high risk of advancing to kidney failure due to IgAN. Patients taking this drug should be aware of its potential side effects and should be monitored regularly for toxicity. With its lower price point compared to Tarpeyo, Filspari may become a more accessible treatment option for those suffering from this chronic kidney disease.

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References

Travere Therapeutics Announces FDA Accelerated Approval of FILSPARIᵀᴹ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy

U.S. FDA approves Travere Therapeutics kidney disorder drug

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‍About the Author

Rich Foreman brings over 30 years of technology leadership to his role of CEO and Co-Founder of KidneySoft.  As founding CTO, Rich led the team that developed the CordicoShield / CordicoFire Wellness App. Cordico was honored with the Sacramento Innovation Award in 2021. After achieving a 7 digit ARR, Cordico was acquired by Lexipol in 2020. Rich has a BS in Industrial Engineering from the University of Washington, an MPA from Troy State University and was an officer in the U.S. Navy. Rich co-authored his book, "Tap into the Mobile Economy." Rich's blog was listed in Top 20 Marketing Mobile Blogs of 2014. He has been featured on KCRA3, NEWS10, 1170 Tech AM PowerDrive, Business Radio Money 105.5, SiliconIndia, the Sacramento Business Journal, and the Sacramento Bee. Rich is also the Founding Director of the Sacramento Chapter of Startup Grind and served a term as Utility Commissioner for the City of Folsom. Rich is a regular contributor to TechWire.net and StartupSac. Rich was the Co-founder of Apptology which was named Small Business of the Year in 2014 by the Sacramento Asian Pacific Chamber. He was also the Founding Chief Technology Officer at Cordico. Cordico was acquired by Lexipol in 2020.  Rich also served 4 years as a Naval Officer in the Civil Engineer Corps.

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Patient Education Disclaimer

This material is for informational purposes only. It does not replace the advice or counsel of a doctor or health care professional. KidneyLuv makes every effort to provide information that is accurate and timely, but makes no guarantee in this regard. You should consult with, and rely only on the advice of, your physician or health care professional.