Drug Approvals in 2016: Europe vs. US

Drug development consultancy, NDA Group, has reported findings from its fourth annual comparison of drug approvals in Europe and the United States. Research conducted by NDA, based on figures from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) websites in January 2017, found a drop in drug approvals in the US but not in the EU.

A total of 74 new drug approvals were granted in the EU and US-19 products were approved in the EU only, 19 products were approved in the US only, and 36 were approved in both regions. The report noted that 17 drugs approved in the EU in 2016, had already received FDA approval in 2015 or earlier. On the other hand, only six drugs registered in the US in 2016 have had EMA approval in 2015 or earlier. Such finding indicates that drug companies tend to apply for approval in the US first before registering their products in the EU. The report emphasises the need for a streamlined global development and commercialization process across the two biggest markets.

The figures showed that 35 approvals were classified as novel drugs (e.g., new active substance [NAS], new molecular entity [NME], or biologic license application [BLA]). Nine were approved only in the EU; the fewest NASs approved by EMA since 2011. Nine were approved only in the US; FDA has not approved this few NMEs/BLAs since 2010. And 17 novel drugs were approved in both continents.  

Of all the new products that received marketing approval in 2016, 30 products underwent special approval procedures such as conditional, fast track, breakthrough, accelerated approval, and priority review-18 in the US, seven in EU, and five in both regions. In many cases, more than one of these pathways was granted per product.

While drug approvals from small- and medium-sized companies have increased both in the EU and US (47%), Big Pharma still holds top ranking in the number of drug approvals (53%). Oncology drugs dominated the list, with noteworthy approvals such as Lartruvo (for the treatment of soft tissue sarcoma, approved in the EU and US), Rubraca (for the treatment of ovarian cancer, only approved in the US), Tecentriq (for the treatment of urothelial carcinoma, only approved in the US), and Venclexta (for the treatment of chronic lymphocytic leukemia, approved in the EU and US).

Terese Johansson, the NDA consultant behind this research commented: “The findings show that FDA has had a significant drop in drug approvals but continues to grant more expedited and nonstandard review approval status than the EMA. The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. The US situation could be explained by the increased use of the shorter nonstandard approval pathways since there has also been a significant increase in complete response letter (CRL). During 2016 FDA issued 14 CRLs, compared to just two in 2015.”

Source: NDA