Glybera withdrawal (2012-2017)
The European Medicines Agency approved Glybera in 2012 as Europe's first gene therapy, priced at roughly 1 million euros per treatment for a rare lipid disorder.
Nearly unused because of high cost and a tiny patient population, its marketing authorization was withdrawn in 2017.
It became a cautionary tale that regulatory approval does not guarantee commercial viability.
Winning approval is not the same as building a sustainable treatment, a risk Beacon's backers weigh as laru-zova nears the FDA.
