Therapy Areas: Inflammatory Diseases
European Medicines Agency (EMA) grants Novartis's iptacopan (LNP023) orphan drug designation for IgA nephropathy (IgAN)
26 October 2020 -

Swiss-based multinational pharmaceutical company, Novartis International AG, announced on Friday that the European Medicines Agency (EMA) has granted an orphan drug designation for iptacopan (LNP023) in IgA nephropathy (IgAN), following a recommendation from the Committee for Orphan Medicinal Products (COMP).

Orphan drug designation is granted to medicines that treat, prevent or diagnose a life-threatening or chronically debilitating rare disease, with a prevalence in the EU of below 5 in 10,000, and with either no currently approved method of diagnosis, prevention or treatment or with significant benefit to those affected by the disease.

IgAN is the most common form of primary glomerulonephritis - an inflammatory kidney disease where abnormal IgA antibody is formed, which results in immune complex deposition in the glomerular mesangium, leading to deteriorating kidney function.

Iptacopan (LNP023) is a first-in-class oral, small-molecule, selective inhibitor of factor B, a key serine protease of the alternative pathway of the complement cascade mediating inflammatory responses. Novartis is planning to initiate Phase III studies of the drug in several indications.

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