INmune Bio Submits Pre-Submission to MHRA for First RDEB Systemic Therapy
INmune Bio has submitted its pre-submission package for CORDStrom™ to UK MHRA, initiating early regulatory feedback aimed at speeding approval of the first systemic therapy for recessive dystrophic epidermolysis bullosa. The company completed three commercial pilot-scale manufacturing runs confirming product consistency and targets full MAA filing by mid-2026.
1. Regulatory Milestone: Pre-Submission to MHRA
INmune Bio formally submitted its pre-submission package for CORDStrom™ to the UK Medicines and Healthcare Products Regulatory Agency to secure targeted scientific and procedural feedback. This step is designed to streamline the eventual Marketing Authorization Application and potentially reduce time to market for the first systemic therapy addressing the severe symptoms of RDEB.
2. Manufacturing Readiness Confirmed
The company completed three commercial pilot-scale manufacturing runs at the CGT Catapult facility in Stevenage, UK, each meeting predefined release criteria for product characteristics. These consistent results validate the company’s readiness for commercial supply and support its regulatory filings.
3. Next Steps and Regulatory Incentives
INmune Bio plans to file the full MAA by mid-summer 2026, followed by EU and US submissions in Q4 2026, pending regulatory alignment. CORDStrom™ holds Orphan Drug and Rare Pediatric Disease designations in the US and stands to benefit from the extended priority review voucher program through 2029.