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Novartis Received EMA PRIME Designation for Iptacopan in C3 Glomerulopathy

Novartis (NYSE: NVS) today announced that the European Medicines Agency (EMA) has granted PRIME designation for iptacopan (LNP023) in C3 glomerulopathy (C3G). PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need.

· 10/09/2020 05:20
Novartis (NYSE:NVS) today announced that the European Medicines Agency (EMA) has granted PRIME designation for iptacopan (LNP023) in C3 glomerulopathy (C3G). PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can potentially reach patients earlier. C3G is an ultra-rare and severe form of primary glomerulonephritis, characterized by complement dysregulation.1,7 It has a worldwide annual incidence of 1–2 per million8 and an approximate prevalence of 10,000 in the US, ~10,500 in Europe, 3,200 in Japan and 32,000 in China9. C3G is commonly diagnosed in adolescents and young adults. The disease has a poor prognosis; about 50% of patient progress to end-stage renal disease (ESRD) within 10 years, and 50–70% experience disease recurrence post kidney transplant.2 Results from a Phase II interim analysis for iptacopan in C3G will be presented at the virtually held American Society of Nephrology (ASN) 2020 Annual Meeting from October 22-25, 2020.