INmune Bio (INMB) said Monday it is planning to submit a biologics license application to the US Food and Drug Administration, as well as marketing authorization applications in the UK and the European Union seeking approval of CORDStrom to treat recessive dystrophic epidermolysis bullosa in pediatric patients.
According to the company, a study showed that CORDStrom lowered itch at three months and led to a sustained reduction of more than 27% at six months in children with severe disease.
INmune plans to submit a BLA this year and will prepare to submit MAAs to the EU and UK in 2026.
Recessive dystrophic epidermolysis bullosa is a genetic skin disorder.
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