FDA Approves FABHALTA® (iptacopan) For Complement 3 Glomerulopathy

FDA Approves New Medication For Complement 3 Glomerulopathy

Complement 3 glomerulopathy (C3G) is a rare kidney disease that affects the way your kidneys function. The complement system (the part of the immune system that protects against infections) malfunctions and causes inflammation and damage to the glomeruli. The U.S. Food and Drug Administration has approved FABHALTA® (iptacopan) for treating adults with C3G.

What Is Complement 3 Glomerulopathy?

C3G begins with the irregular activation of the complement system (which protects against infections). C3G is caused by genetic problems (inherited and non-inherited) that control the body’s complement system. Antibodies can also be responsible for the activation of C3G. 

This causes damage to the kidney glomeruli, which are responsible for filtering blood and producing urine. Damage to the C3G causes “waste products and toxins to build up in the blood, which decreases the kidneys’ ability to balance salts and minerals, decreases urine production, and causes continued kidney damage.”

Symptoms Of C3G:

• High levels of protein in the urine
• Blood in the urine
• Reduced urine output
• Swelling in the hands, feet, and ankles
• High blood pressure
• Dark and foamy urine
• Feeling weak and tired
• Progressive kidney failure

Treatment And Prognosis

There isn’t a cure for C3G. But there are treatment options to help slow it down and manage symptoms. “Approximately half the people with C3G develop kidney failure within 10 years of diagnosis.” It is estimated that C3G affects 2-3 out of every 1 million people. A kidney transplant is an effective option, but there is a high risk of disease recurrence.

What Is FABHALTA® (iptacopan)?

This is a prescription medication that reduces protein in the urine for those who are at risk of their kidney disease progressing. FABHALTA® (iptacopan) was studied (NCT04817618) in a group of 74 adults who had C3G. After a 6-month treatment period, all patients treated with FABHALTA® (iptacopan) had a reduction in 24-hour UPCR (urine protein-to-creatinine ratio) for 12 months. 

FABHALTA® (iptacopan) is a medication that affects your immune system, so it may lower your body’s ability to fight infections. It also increases your chances of getting Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or fatal if not recognized and treated early. While taking FABHALTA® (iptacopan), you should be revaccinated according to current medical guidelines.

Conclusion

Complement 3 glomerulopathy is a group of conditions that affect your immune system and prevent your kidneys from filtering blood as well as they should. Most cases of C3G don't have a clear cause, but gene mutations and autoantibodies may be responsible. There is hope for better treatment with the FDA approval of FABHALTA® (iptacopan). Speak with your doctor if you are interested in trying this medication.

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