Quoin Pharmaceuticals: Clear Clinical Path Forward for Lead Product Candidate in Europe
Following the receipt of Scientific Advice from the European Medicines Agency (EMA), specialty pharmaceutical company, Quoin Pharmaceuticals (Nasdaq: QNRX), has a clear path forward for the clinical development of its lead product candidate for the European market.
The EMA truncated the standard review period for Quoin’s Briefing Submission and waived the requirement for an in-person meeting, and has provided the company with comprehensive, constructive Scientific Advice for the clinical and regulatory development of the product.
- Quoin is focused on the clinical and regulatory development of QRX003 for Netherton Syndrome (NS) in the US and Europe;
- Receipt of this Scientific Advice from the EMA further supports the company’s development activities for QRX003;
- Quoin initiated its US clinical trial evaluating the safety and efficacy of QRX003 in June;
- Early Access Programs could result in the product becoming available to NS patients in advance of formal regulatory approval.
Receipt of the EMA’s Scientific Advice is an important milestone for patients living with Netherton Syndrome, a devastating genetic disease with no approved treatment or cure. Quoin has established a global network of eight marketing partnerships for QRX003 that spans 60 countries including Greater China, the Middle East, Canada, Australia/New Zealand, Latin America as well as Central and Eastern Europe and Turkey.