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NDA Group Releases Data Comparing FDA and EMA drug approvals in 2020

NDA Group Releases Data Comparing FDA and EMA drug approvals in 2020

Record year for novel drug approvals

Small and Medium-Sized Companies continue the positive trend

Pandemic disruptions did not prevent significant advancements

Stockholm, Sweden (March 30, 2021) – Today NDA Group announced their findings from the eighth 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 EMA and FDA websites in January and February 2021 – found that the positive trend in approvals observed over the last couple of years took a noticeable leap forward in 2020. For 2020 there were a total of 133 new drug approvals granted in the US and EU, an impressive increase against recent years’ average.

Of these new products, 51 were approved only in the EU, 71 only in the US, and 11 were granted in both regions. 69 of the drugs were classified as novel drugs of which 20 were approved only in the EU, 48 only in the US and 1 in both regions. These figures indicate that last year was a year of significant differences in drug approvals across the two regions, where each region assessed and approved products that the other region did not to a greater extent than has been the case the last few years.

Johan Strömquist, CEO, NDA Group “It is encouraging to see that, despite the Covid 19 pandemic, innovative drug developers were able to exceed previous years number of submissions, and that the drug regulators have been so productive. At the same time, it is troubling to see the big difference in what products have actually been approved in the two regions. This discrepancy indicates that companies are not leveraging the opportunities available for parallel or closely sequential filings across the EU and US.”

“Given that 2020 was a record year in terms of new drug approvals, I am particularly proud to see that NDA continues to support such a large proportion of new drugs approved in the EU market. Last year we were involved in 42% of the products that were approved by the European Commission. I am also pleased to see that we supported close to half of the US companies that achieved a European approval over the last three years.”

Dr Ingela Loell, NDA’s researcher behind the conclusions commented:
“2020 will go down in history as the year of the pandemic, and it still did not put a damper on innovation. A lot of focus in the media has rightly been placed on the development of vaccines and treatments for infected, but 2020 really pushed the frontiers of advanced therapies and products with gene editing components.”

“We saw approvals of life-saving and life-changing treatments, like Zolgensma, originally developed by AveXis and commercialised by Novartis, a gene therapy successfully addressing spinal muscular atrophy. Or Vilteps by NS Pharma, an exon 53 skipping treatment aiming to correct a naturally occurring genetic mutation of a protein aggravating Duchenne Muscular Dystrophy. These are but two examples among many of how advanced therapies are continuing to make inroads into medical practice to change the lives of patients worldwide. ”

Highlighted in the report released today are also some noteworthy Orphan approvals. Although the SME contribution in previous years have been explained by the increased share of orphan drugs and the increased opportunities for small companies to take their product all the way, 2020 seems to break slightly with this trend.

Ingela Loell continues:
“Orphan drugs continue to dominate an important section of the new drug approvals, with 34% of the total products having an orphan designation. In spite of the advantages for companies to focus their development in this field, and the boom that we’ve seen in recent years, the proportion of orphan products remained pretty stable through 2020.”

“Looking at SME contribution to the field we’ve also concluded that the proportion of orphan drugs among the small companies is reasonably comparable to the total pool of companies, which goes counters to what we’ve learned in previous years.”

Successful Exploration of Novel Drugs
The pooled statistics showed that of the new drug approvals 69 products were classified as novel drugs (e.g., NAS, NME or BLA), 20 of these were approved only in the EU, 48 only in the US and one were approved in both regions. In absolute numbers this is an impressive achievement, but as a proportion of the total number of products approved it is an actual decrease since previous years.

Big pharma represented 37% of the new drug approvals in 2020 vs 63% of the new approvals originating from small and medium-sized pharma. For big pharma, this is another year of decreased proportion of drug approvals. Of all new products that received marketing approval in 2020, 41 products underwent special approval procedures like Conditional, Fast Track, Breakthrough, Accelerated Approval and Priority Review, 33 only in the US, seven only in EU and one granted in both the US and EU. In many cases, more than one of these pathways was granted per product.
To explore the full Status of New Drug Approvals for the 2020 report, visit our website


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Last Updated: 30-Mar-2021