Roche's Gazyva/Gazyvaro Gains EU CHMP Nod for Lupus Nephritis
- CHMP recommends Gazyva/Gazyvaro for lupus nephritis based on phase II and III trials.
- Gazyva/Gazyvaro showed a 46.4% complete renal response in trials.
- FDA decision on Gazyva/Gazyvaro expected this year.
- Gazyva/Gazyvaro is being studied for various kidney-related diseases.
CHMP Recommendation
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva/Gazyvaro for treating adult patients with active Class III or IV lupus nephritis. This decision is based on positive results from phase II NOBILITY and phase III REGENCY studies.
Clinical Trial Results
In the REGENCY study, 46.4% of participants receiving Gazyva/Gazyvaro plus standard therapy achieved a complete renal response, compared to 33.1% with standard therapy alone. The treatment also showed a significant reduction in corticosteroid use and improved proteinuric response.
FDA Submission
Data from the phase III REGENCY study has been used to file a supplemental Biologics License Application with the US FDA, with a decision expected this year.
Ongoing Research
Gazyva/Gazyvaro is under investigation for other conditions, including systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in pediatric lupus nephritis cases.
Source: Roche