Glybera (alipogene tiparvovec) made history on November 2 when the European Union approved its marketing application, making the gene therapy the first to win approval by Western regulators.
In many ways, the story of Glybera is the story of AAV and gene therapy itself.
Looking ahead, is the next step approval by FDA? And will they approve it? I don’t really know. I would guess uniQure is trying to partner with someone in the U.S. who may be better positioned to take this forward to FDA. It’s unclear when, or if, we’ll see an approval for Glybera in the U.S.
View the original article here: Glybera’s Story Mirrors that of Gene Therapy
