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FDA Approves First Treatment for Adults with Complement 3 Glomerulopathy, a Rare Kidney Disease, to Reduce Proteinuria
FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Fabhalta is an oral capsule, taken twice daily. Recommended dosing is available in the prescribing information.
C3G is a rare disease that causes inflammation and damage to the kidney glomeruli, which are responsible for filtering blood and producing urine. In C3G, the complement system (proteins in the blood that play a critical role in the immune system) becomes abnormally activated. Complement products can become lodged in the glomeruli causing them to become leaky and harming their ability to filter blood. Waste products and toxins then build up in the blood, which decreases the kidneys’ ability to balance salts and minerals, decreases urine production, and causes continued kidney damage.
Fabhalta increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. Patients should complete or update vaccination for encapsulated bacteria at least 2 weeks before the first dose of Fabhalta, unless the risks of delaying treatment outweigh the risks of developing a serious infection. Health care providers should monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
Fabhalta may increase total cholesterol, LDL-cholesterol, and serum triglycerides. Health care providers should monitor patients’ serum lipid parameters periodically during treatment with Fabhalta and initiate cholesterol-lowering medication, if indicated.
Fabhalta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
The most common adverse reactions (reported in at least 10% of patients) to Fabhalta were nasopharyngitis (common cold) and viral infections.
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