Dimerix welcomes FDA approval of similar kidney disease drug, using accelerated approval pathway
Health & Biotech
Health & Biotech
Dimerix has welcomed news late last week that the US Food and Drug Administration (FDA) has approved the drug Sparsentan for Immunoglobulin A nephropathy (IgAN) another type of rare (orphan) kidney disease.
The company says this approval is further validation of the opportunity for its drug candidate DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) kidney disease – which is currently in Phase-3 trials with first interim data expected by the end of the year.
Notably, Sparsentan, an angiotensin receptor blocker fused with an endothelin-A receptor antagonist, is also being developed for FSGS, and is the only other drug candidate in a Phase-3 program for FSGS.
“This is really great validation for Dimerix (ASX:DXB), because it has locked in the pricing for Sparsentan in IgAN in the US of US$9,900 per month or $120,000 per year per patient, and that will likely be the same for FSGS – which provides a strong pricing precedent for us,” CEO and MD Nina Webster said.
For context, the average price of an orphan drug in the US is around US$7,000 per month or $80,000 per year.
This accelerated approval has been granted for another orphan kidney disease using surrogate endpoints, providing further precedent for the potential faster pathway to market available for novel compounds such as DMX-200.
Making it to Phase-3 means Dimerix has already demonstrated safety and efficacy of its drug candidate – and it’s also means the probability of getting to market is much higher.
Compare this to Sparsentan, for which the approval comes with a black box toxicity warning for liver and foetal toxicity, as well as numerous potential drug/drug interactions.
As a result, the company that makes Sparsentan, Travere Therapeutics, will have to run a risk evaluation and mitigation strategy (REMS) as part of the approval.
This means that Doctor’s will have to be specially trained to prescribe sparsentan and will also have to monitor patients very regularly to assess for any signs of toxicity.
“In contrast, DMX-200 has demonstrated a very strong safety profile, and no such limitation is anticipated” Webster said.
Not to mention, a restrictive REMS likely means a more limited market for Sparsentan. When you consider kidney disease alone cost the US healthcare system $88 billion in 2021, with payers and physicians in the US now incentivised to prevent the onset of kidney failure, this presents a significant opportunity for Dimerix.
“While we believe we are complimentary to sparsentan, it leaves the market wide open for candidates such as DMX-200,” Webster said.
The first interim analysis is anticipated towards the end of 2023, and success in the second interim analysis, or accelerated approval endpoint, may mean the company could take the drug to market mid-study.
This article was developed in collaboration with Dimerix Limited, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.