image credit: Vecteezy

BioMarin resubmits haemophilia A gene therapy to the EMA

June 29, 2021

BioMarin initially withdrew the EU marketing application for the gene therapy – also known as Roctavian – last year, after stating that it was unable to provide the data needed to resolve a ‘major objection’ raised by the EMA’s Committee for Advanced Therapies.

The first EMA filing contained interim results from 32 adults with severe haemophilia A in a Phase III trial.

According to BioMarin, the EMA had requested the full 52-week results from all 134 patients enrolled in the study.

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