UK MHRA OKs PIP for Ebstrocel, Fast-Tracking 2026 MAA and 2027 US Filing
INMB•MHRA approved INmune Bio’s Pediatric Investigation Plan for Ebstrocel in treating Recessive Dystrophic Epidermolysis Bullosa in under three months, accelerating the UK MAA target for 2026 and US filing in early 2027. Approval covers approximately 300 UK pediatric patients and integrates MHRA’s guidance on phase-3 trial protocols.
1. PIP Approval Milestone
The MHRA granted Pediatric Investigation Plan approval for Ebstrocel in under three months, endorsing the clinical data package and confirming no objections to safety or efficacy claims. This accelerated review validates the company’s data and allows integration of minor adjustments into the phase 3 open-label trial protocol.
2. Aligned Regulatory Timeline
The PIP approval remains strictly aligned with the timetable for a UK Marketing Authorization Application filing in 2026 and a US Accelerated Approval submission in early 2027. This twin-track regulatory strategy enables pursuit of conditional marketing authorization this year while conducting a confirmatory registration trial in 2027.
3. Pediatric RDEB Patient Framework
The approved PIP establishes a scientific justification and dosing framework for treating approximately 300 UK children with Recessive Dystrophic Epidermolysis Bullosa, addressing chronic wounds, intractable itch and severe pain. It sets the stage for early market access and post-marketing commitments needed for full authorization.
