NDA Group releases findings from comparative analysis of drug approvals in US and EU

Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland.

This year’s report has highlighted the continued differences between the two regions and the need for a global approach to drug development to ensure success across both continents.

The comparison has been based on the preliminary research figures distilled from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites in January 2018.

From this analysis, NDA Group revealed that have been more approvals overall — including approvals of new drugs — when compared with figures from 2016 when there was a drop off. During 2017 there were a total of 103 new drug approvals granted in both regions: 15 were approved only in the EU; 52 only in the US; and 36 approved in both the US and EU. Out of the approvals, 56 drugs were classified as novel and of these 6 were approved in the EU only, 27 in the US only and 23 in both regions.

“We are pleased to see that the drug approvals are increasing again compared to 2016 year’s figures. It’s also interesting to see that for the first time since we started to analyse the drug approvals small and medium sized pharma are ahead of big pharma,” said Johan Strömquist, CEO, NDA Group. “Our analysis for 2017 shows that NDA maintains an exceptional position in supporting new drug product approvals in Europe. During the last five years NDA supported over 40% of the new drugs approved with a broad range of services. This is particularly exciting as an increasing proportion of products are emerging based on highly innovative and ground-breaking technologies. This is where we at NDA Group truly excels.”

“The findings released today show some precedence setting new approvals,” commented Dr Terese Johansson, NDA’s consultant behind the research. “In the US the Keytruda, (pembrolizumab) approval in oncology demonstrates the shift from defining cancers by the site at which they occur toward a definition by the molecular changes that drives the tumorigenesis. This approval is likely to have implications for how the drug development process is pursued in the future, particularly in oncology, but most likely also for other therapeutic areas as science progresses. Looking at the therapeutic areas, the far busiest was oncology. With a total of 27 new oncology approvals, so far 12 of these are only approved in the US. Moreover, the first digital pill (Abilify MyCite, aripiprazole) has seen the light of day in the US.”

A further revelation of the report was that of the orphan approvals. As more treatments for orphan drugs are beginning to reach the market the pricing of these drugs is becoming more important.

Johansson continued: “Drug developers are meeting the treatment demand from the patients and physicians but are the payers willing to pay the price? Drug developers will benefit from being prepared early on to develop strategies to ensure patient access and affordability of their orphan drugs.”

Small and medium sized pharma were found to come out on top with 51% of the new approvals compared to 49% from big pharma — which is a decrease from previous years.

Out of all the marketing approvals granted in 2017, 43 products underwent special approval procedures like conditional, fast track, breakthrough, accelerated approval and priority Review, 33 only in the US, six only in EU and four granted in both the US and EU. In many cases more than one of these pathways was granted per product

NDA staff can be found at booths C 72 and 73 at the show, DIA Europe, and will be presenting on various topics during the show.