EU clinical trial numbers ‘really worrisome’ for future CGT approvals

Experts have raised their concern about future CGT approval rates in Europe based on the number of clinical trials in the region lagging behind both the US and Asia. 

While optimism surrounds cell and gene therapies (CGTs) with 10 approvals between the US and Europe for nine CGT products in 2022, their challenges remain a hot topic in the Life Sciences space. Conversations include calls for new innovative payment models, patient access worries due to different healthcare systems, and difficult the regulatory pathway to approvals.  

A panel discussion at Phacilitate’s Advanced Therapies Europe (ATE) in Lisbon, Portugal discussed the European landscape in the CGT space this week, highlighting the lack of clinical trials taking place in the continent when compared to the US and Asia. 

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“Europe has around half the number of clinical trials compared to the Asia-Pacific region,” said Elizabetta Zanon, director of EU public affairs and advocacy at the Alliance for Regenerative Medicine (ARM). “In Phase I clinical trials, the European Union (EU) has around 80, whereas there are more than 300 in North America and APAC.” 

While Zanon acknowledged it might be a little early to predict what will happen in 2024, “it is predicted that three times more regulatory approvals will happen in the US compared to approvals [made] under the European Medicines Agency (EMA).”  

She described this prediction as “really worrisome” and posed the question, “does this mean in the future we will have less therapies being approved in Europe?” 

Miguel Forte, CEO of Kiji Therapeutics, reinforced Zanon’s comments adding, “we need lots of clinical trials, you need to have them to have future approval.” 

Chicken and egg

Anthony Davies, CEO of Dark Horse Consulting, described the mutual importance of clinical trials and commercialization as a “chicken and egg situation” because “you do not get commercial approvals without clinical trials.”  

With a clear need for clinical trials to happen in order to commercialize a product, Zanon noted the importance of looking “at the whole ecosystem” and receiving “action at an EU level and a national level.”  

Despite the lower numbers for clinical trials in Europe compared to other geographical locations, Davies remained positive about the European CGT landscape and closed the panel by saying he thinks “the field is thriving, but it could thrive more.”