Treatment

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Novartis's medication Atrasentan (Vanrafia) , which is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

A Selective Endothelin (A) Receptor Antagonist

Atrasentan is a potent and highly selective endothelin A (ETA) receptor antagonist. By blocking ETA receptors, the treatment aims to reduce inflammation, improve renal blood flow, and decrease proteinuria, an important marker of kidney damage and disease progression.

Clinical Study Demonstrates Significant Reduction of proteinuria

The SFDA’s decision was supported by clinical study results showing a significant reduction in proteinuria and sustained improvements in kidney function compared to placebo. These findings highlight atrasentan’s potential as a promising treatment option for patients with limited available therapies.  

Designation Does Not Constitute Marketing Authorization

The SFDA emphasizes that this designation allows Atrasentan to be submitted and reviewed under the Breakthrough Track, subject to specific regulatory controls and mechanisms. This designation does not constitute a marketing authorization of the drug in Saudi Arabia. A final decision regarding registration will be announced following a full technical and scientific evaluation of the complete registration dossier.

The SFDA Breakthrough Medicine Program Expedites Access to Targeted Treatments

The Program aims to expedite access to innovative and effective treatments for serious diseases where existing therapies may be inadequate. To qualify for this designation, a drug must have completed clinical trials demonstrating promising efficacy and safety, offer a significant therapeutic advantage over current options, target serious or life-threatening conditions, and exhibit a positive benefit-risk balance. Notably, the product should not be registered with any other regulatory authority at the time of application.

For further information about the Breakthrough Medicines Program, please refer to the guide available on the SFDA website: https://sfda.gov.sa/en/regulations/89310 or contact the SFDA via email at Designation.Drug@sfda.gov.sa.