There is a lot of talk about how cell and gene therapy are going to change medicine, so why have only a few of them reached the market?
Over the last decade, only 14 advanced therapy medicinal products (ATMPs) – that is, cell and gene therapies – have received approval in Europe. With four withdrawals, only 10 of them still have a valid marketing authorization.
That is a stark contrast with the fact that there have been over 500 clinical trials using ATMPs in the EU since 2009. But the reality is that it’s a bit too soon to be expecting results – many of these technologies are brand new and decades-old discoveries are only just reaching the market. For example, the development of Strimvelis, approved in 2016, took more than 20 years. The approval of Chondrocelect in 2009 took nine years since its developer, TiGenix, was founded.
Holoclar initially seemed like an exceptional case: research and development started around 1996 and the first clinical results were published just a year later. But one of its developers, Graziella Pellegrini, reported the product was under development for a total of 25 years. So those excited about CRISPR therapies, based on a gene-editing technology that was only developed in 2012, will still have to wait.
If the time scale wasn’t daunting enough,
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Published on Mon, 21 Sep 2020 09:50:19 +0000 and brought to you by Apptigent PowerTools