pharmaphorum August 8, 2024
Phil Taylor

Novartis has claimed accelerated approval from the FDA for a second indication for Fabhalta – IgA nephropathy (IgAN) – as it charts a course to blockbuster sales for the drug.

The US regulator has cleared Fabhalta (iptacopan) for the reduction of proteinuria in adults with primary IgAN who are at risk of rapid disease progression, making it the first complement inhibitor for the rare kidney disease.

Fabhalta is already approved in the US, EU, and Japan as a therapy for paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder, and is the first oral alternative to injectable or infused complement therapies like AstraZeneca’s Soliris (eculizumab) and Ultomiris (ravulizumab) and Apellis’ Empaveli (pegcetacoplan), which are not used to treat IgAN.

The IgAN...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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