dm+d

25502511000001105

Refrigerated Storage

Gazyvaro Roche Products Ltd

Roche Products Ltd
Gazyvaro
1000mg concentrate for solution for infusion

Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

12 October 2022
London MI Service

New Medicines

Gazyvaro (EU), Gazyva (US) Proliferative lupus nephritis

Information

Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech

Development and Regulatory status

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

Category

Monoclonal antibody that attaches to CD20 on B cells
Lupus nephritis is a complication of systemic lupus erythematosus, an autoimmune disease. Up to 60 percent of those with SLE will develop lupus nephritis, and up to 25 percent develop end-stage renal disease [1]. Lupus affects about 1 in 1,000 people in the UK. It is about six times more common in women than in men and more common in those of Caribbean, Chinese or Asian descent [2].
Proliferative lupus nephritis
Intravenous infusion

Gazyvaro (EU), Gazyva (US) Membranous nephropathy

Information

Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype
In membranous nephropathy, widespread thickening of the glomerular basement membrane occurs. It is a relatively common cause of nephrotic syndrome in adults. It progresses to end-stage kidney disease in 30-50% of patients. The remainder with idiopathic membranous nephropathy has a complete or partial spontaneous remission of nephrotic syndrome with stable renal function [1]. It has an estimated incidence of 8-10 cases per 1 million [2].
Membranous nephropathy
Intravenous infusion

Gazyvaro (EU), Gazyva (US) Serologically active extra-renal systemic lupus erythematosus (SLE)

Information

Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype
Lupus affected nearly 1 in 1,000 of the population in 2012 in the UK. The age-standardised incidence in the UK is 8.3 per 100,000/year for females and 1.4 per 100,000/year for males in the UK [1].
Serologically active extra-renal systemic lupus erythematosus (SLE)
Intravenous infusion