Funding for Early Innovation Drugs Slows Down in Spain

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The approval for early innovation products is gaining momentum throughout the EU. However, lack of confidence on the results presented and suboptimal quality access to drugs are causing this momentum to slow in Spain. Experts Ana Mozetic, Carlos Ardévol, and Paloma Gutiérrez outline how manufacturers can overcome these hurdles. 

Early innovation authorizations are gaining momentum in the EU

Over the past few years, a growing number of early innovation products – drugs approved with only phase I/II trials and shorter clinical development processes – have achieved approval from the European Medicines Agency (EMA) with limited evidence. This trend is expected to continue in the coming years as drugs become more “specific” (i.e., targeting a specific mutation).

Data from the European public assessment reports published since 2016 shows that approximately 300 new active substances have been authorized by…