FDA approves commercial brand name for Dimerix’s kidney disease drug
Health & Biotech
Health & Biotech
The US Food and Drug Administration (FDA) has given Dimerix conditional approval for the brand name QYTOVRA for its Phase 3 clinical drug candidate in rare kidney disease focal segmental glomerulosclerosis (FSGS).
For drugs offered in the United States, brand names must be reviewed and approved by the FDA before the drug may be marketed and sold – with the aim of ensuring patient safety by mitigating the potential for medication errors or confusion between the proposed new drug name and any existing drug names.
FSGS is a rare disease that attacks the kidney’s filtering units, where blood is cleaned, causing irreversible scarring which leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation.
Around 80,000 people suffer from the disease in the US and around 220,000 worldwide – making it a potential billion-dollar market opportunity for the company.
And because there is no effective treatment, Dimerix (ASX:DXB) has already received Orphan Drug Designation for QYTOVRA in both the US and Europe for FSGS.
The benefits of Orphan Drug Designation include various development incentives including: seven years (FDA) and 10 years (EMA) of market exclusivity if regulatory approval is received, exemption from certain application fees, and a fast-tracked regulatory pathway to approval.
“As our potential new treatment for this rare kidney disease moves closer to market, the name DMX-200 for FSGS had been replaced by the intended commercial brand name QYTOVRA,” Dimerix MD and CEO Dr Nina Webster said.
“The potential commercial value of QYTOVRA continues to increase as we successfully execute on each element of the development program.”
This approval from the FDA is an entirely separate process to trademark applications made with the United States Patent and Trademark Office (USPTO).
QYTOVRA is already protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042 and the trademark registered in many key territories.
The company has also made a formal application to the United States Adopted Names (USAN) Council, which granted QYTOVRA a USAN designation for repagermanium, and which will appear in the United States Pharmacopeial Convention list of International Drug Names.
The Phase 3 trial is underway to study the efficacy and safety of QYTOVRA in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Once the ARB dose is stable, patients will be randomised to receive either QYTOVRA (120mg capsule twice daily) or placebo.
“We have surpassed our first 72 patients randomised into this Phase 3 trial, as we move towards the outcome of Part 1 analysis in March 2024,” Dr Webster said.
“In parallel, we continue to engage with the FDA, EMA and NMPA as well as prospective marketing partners.
“We are excited about the prospect of making this unique product available to patients in all major markets and, in doing so, deliver strong financial returns back to Dimerix and its investors.”
Last patient data collection is scheduled for 26 February 2024 and first analysis is expected to be reported on, or around, 15 March 2024.
In parallel with its Phase 3 clinical trial, Dimerix has also been working closely with its commercial manufacturing partner to produce the required commercial registration batches and associated stability data to support the shelf-life and those regulatory filings.
This article was developed in collaboration with Dimerix, 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.