Trends in FDA and EMA drug approvals in 2018

New research highlights the continued differences between the USA and European to drug approval, and the need for a global approach, to drug development to ensure success across both continents.

This was the conclusion of sixth annual comparison of drug approvals from Sweden-based NDA Group during the international BIO Europe Spring meeting in Vienna, Austria.

This year’s report – based on preliminary research figures distilled from the European Medicines Agency and Food and Drug Administration websites in January and February 2019 – found that the positive trend in approvals observed in 2017 continued in 2018. For 2018 there were a total of 103 new drug approvals granted in the USA and EU. Of these new products, 15 were approved only in the EU, 52 only in the USA, and 36 were granted in both regions. 56 of the drugs were classified as novel drugs, six were approved only in the EU, 27 only in the US and 23 in both regions.

“It is very exciting to see how the orphan space is increasingly conquered by small biotechs, who, given the lighter trial burden are able to carry their product all the way to market. The trend that we noticed in 2017 is strengthened in 2018 with an even greater proportion of small companies going all the way,” said NDA Group chief executive Johan Strömquist.

“Given the larger number of innovative products that have come through the systems in the last two years, I am very encouraged to see that NDA continues to support such a large proportion of new drugs approved in the EU market. In spite of the increase we have still been involved in more than 40% of the new drugs approved by the European Commission. This is quite a remarkable achievement,” he added.

NDA’s consultant behind the research, Dr Anna Leitgeb, commented:“2018 was another fantastic year with over 100 new therapeutic drugs approved in EU and US. Interesting new techniques are now approaching the drug development scene. The findings released today include a number of firsts, as well as much awaited treatments for conditions where the options have been few in the past.”

Highlighted in the report released are also some noteworthy Orphan approvals. With more treatments for orphan diseases hitting the market the pricing of these drugs becomes increasingly important.

Dr Leitgeb continues: “Last year’s trend of increased orphan focus, opening up the field for SMEs to get all the way to marketing authorisation, continues. As the field is getting increasingly crowded with highly efficacious novel treatments the question is how much society is willing to pay for these medicines. Even if the product is cost effective over the long run, are we able to afford it?”