Fierce Pharma December 6, 2023
Novartis has gained the first of what it hopes are several FDA approvals for its factor B inhibitor iptacopan, dubbed two months ago “a pipeline in pill,” by analysts at ODDO BHF.
The United States regulator has given a thumbs up to iptacopan to treat paroxysmal nocturnal hemoglobinuria (PNH). Known commercially as Fabhalta, it becomes the first oral monotherapy approved by the FDA for the rare blood disorder, which affects 10 to 20 people per one million worldwide.
Novartis has big ambitions for iptacopan and is lining it up to address other complement-mediated renal and hematological diseases, including primary immunoglobulin A nephropathy (IgAN), also known as Berger’s disease. Analysts at Jefferies have pegged iptacopan’s peak sales potential at $3.6 billion.
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