The recent decision in Europe to not recommend Amsterdam Molecular Therapeutics’ (AMT’s) gene therapy Glybera for approval is the latest in a string of failures for this segment. Details on AMT’s uphill battle with getting the drug approved can be read here and may signal to other developers what to expect. While the science behind gene therapy have come a long way, proving efficacy and navigating the regulatory pathway remain roadblocks. Had AMT received the green light for Glybera, it would have become the first gene therapy approved outside of China. The only gene therapy currently on the market is Shenzhen SiBiono GeneTech’s Gendicine, which received the go-ahead in October 2003 for head and neck squamous cell carcinoma. But one report predicts that the gene therapy market will reach $316 million by 2015 driven by high demand. What are your predictions for the gene therapy market?
Do you think a gene therapy will receive either FDA or EMA approval in the next two years?