EMA report states that Glybera (alipogene tiparvovec) from uniQurelacks efficacy and has a negative benefit risk ratio for LLD.
Cached in a SEC filing (9 April), but not referred to in press releases, is a summary of a EMA report that concluded after six years of development that Glybera (alipogene tiparvovec) from uniQure lacked efficacy and had a negative benefit risk ratio.The drug had faced earlier rejections from EMA for lack of clinical benefit but was approved in 2012. The report raises questions about the adeno-associated vector (AAV) platform that supports the drug.
Comment: Commentators criticize uniQure for its handling of price sensitive information and for its failure to sell any commercial quantities of the drug since its approval two years ago.
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