UniQure Hemophilia B Gene Therapy Changes Ignite A Race To Market
UniQure is switching the gene therapy it plans to move into a pivotal trial in hemophilia B patients because the new version could have clinical benefits. Regulatory agencies in the US and Europe have given the change a green light, and uniQure plans to begin a pivotal trial in 2018.
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The Dutch company's update on AMT-061 and the initiation of a pivotal trial called HOPE-B of around 50 patients could put the product in pole position to be the first gene therapy on the market for the severe orphan blood clotting disorder.
Spark's Luxturna is all but guaranteed to reach the US market as the first gene therapy following a unanimous positive FDA advisory committee review. Discussions about cost and value are sure to intensify.
UniQure’s gene therapy, AMT-060, has been accepted into the European Medicines Agency’s priority medicines scheme, PRIME, a move likely to intensify the race to market of a small group of gene therapies for hemophilia B, all currently in Phase I/II studies.