NDA Group releases data comparing FDA and EMA

UPPLANDS VÄSBY, Sweden—On April 12, just a few days ahead of this year’s DIA Europe  meeting in Basel, Switzerland, the NDA Group announced findings from its fifth annual comparison of drug approvals in Europe and the United States. The figures highlight the continued differences between the two regions and the need for a global approach to drug development to ensure success across both continents.

This year’s report—based on preliminary research figures distilled from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) websites in January 2018—found that once again, there were more approvals and also more novel drugs approved compared to 2016’s drop. For 2017, there were a total of 103 new drug approvals granted in the United States and the European Union. Of these new products, 15 were approved only in the EU, 52 only in the U.S. and 36 were granted in both regions. Fifty-six of the drugs were classified as novel drugs, six were approved only in the EU, 27 only in the U.S. 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 analyze the drug approvals small and medium-sized pharma are ahead of Big Pharma,” said Johan Strömquist, CEO of the 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 percent 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 groundbreaking technologies. This is where we at NDA Group truly excels.”

“The findings released today show some precedence setting new approvals. In the U.S., 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,” added Dr. Terese Johansson, NDA’s consultant behind the research. “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 U.S. Moreover, the first digital pill (Abilify MyCite, aripiprazole) has seen the light of day in U.S.”