The European Medicines Agency (EMA) has agreed to review a conditional marketing authorization (CMA) application for a drug to treat a rare kidney disorder.
The news was announced today (August 21) by CSL Vifor and Travere Therapeutics Inc, and, if approved, the companies say sparsentan will address a significant unmet need in treating IgA nephropathy – a leading cause of end stage kidney disease (ESKD).
The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.
Klaus Henning Jensen, chief medical officer of CSL Vifor, said: “The acceptance of the EU regulatory application for sparsentan marks a major milestone towards our goal of bringing this first-in-class therapy to the patients suffering from IgAN, for which there are currently no approved non-immunosuppressive therapies.
“We look forward to working closely with our partner, Travere, through the EMA review process with the aim to bring this innovative treatment option to patients living with IgAN in Europe.”
Licensing agreement between CSL Vifor and Travere Therapeutics
Swiss drugmaker Vifor Pharma and U.S.-based Travere Therapeutics entered into a joint collaboration and licensing agreement in September last year (2021) for the commercialization of sparsentan in Europe, Australia and New Zealand.
Jula Page, chief medical officer of Travere Therapeutics, said: “Following U.S. FDA’s acceptance and granting of priority review of the NDA for sparsentan for IgA nephropathy in the U.S., we continue to make great progress towards our goal of enabling sparsentan to become a new treatment standard for rare kidney disorders, if approved.
“The acceptance of the CMA application marks an important next step on our pathway to expanding access to sparsentan as the first non-immunosuppressive treatment option for IgA nephropathy in Europe, if approved. We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.”
The EMA filing is supported by positive topline interim results from the ongoing pivotal phase 3 PROTECT Study of sparsentan in IgAN, as well as supportive data from additional clinical studies.
The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance.
After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients.
Preliminary results at the time of the interim assessment suggested that sparsentan had been generally well-tolerated to date in the study and consistent with its overall observed safety profile.
If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
Sparsentan is currently also being evaluated in the pivotal phase 3 DUPLEX Study for the treatment of focal segmental glomerulosclerosis (FSGS), another rare progressive kidney disorder and leading cause of end-stage kidney disease.
Sparsentan has been granted Orphan Drug Designation for the treatment of IgAN and FSGS in Europe and in the U.S.