UniQure announced today that the company has presented the data from the AMT-130 therapy to the regulators in the UK (MHRA).
Some of you may remember that UniQure presented promising results from the study last September. The company expected to present the study results to the US regulators (FDA) and request market approval. However it turned out that the FDA were negative to review the data, because the number of participant in the study is very limited. Now UniQure has been in meetings with the UK regulators and they are positive to review the data for market access.
“This is very exciting”, says EHA president Astri Arnesen. “We are very happy that the MHRA has agreed to review the data and based on their evaluation potentially give the therapy market access. We look very much forward to the next steps. For the HD community this is a good day!”
