dm+d

Unassigned

New Medicines

Immunoglobulin A (IgA) nephropathy (Berger disease)

Information

New molecular entity
Novartis
Novartis

Development and Regulatory status

Phase II Clinical Trials
Phase III Clinical Trials
Phase II Clinical Trials
Yes

Category

First-in-class, orally available, small molecule, low-molecular weight complement factor B inhibitor
IgA nephropathy is the most common form of idiopathic glomerulonephritis leading to chronic kidney disease (CKD) in developed countries. In most cases it follows a benign course, however between 30% to 40% of patients will progress to end-stage renal disease within 20 years [1].
Immunoglobulin A (IgA) nephropathy (Berger disease)
Oral

Atypical haemolytic uraemic syndrome - in patients who are naive to complement inhibitor therapy

Information

Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

First-in-class, orally available, small molecule, low-molecular weight complement factor B inhibitor
HUS is a rare disorder with an annual incidence of 6.1 cases per 100,000 children aged under 5 years (compared with an overall incidence of 1 to 2 cases per 100,000) [1].
Atypical haemolytic uraemic syndrome - in patients who are naive to complement inhibitor therapy
Oral