The U.S. FDA has approved fewer drugs and biologics in the first half of 2022 than in each of the five prior years and only one new molecular entity has received clearance since the end of May. While the volume of regulatory news is slightly down from last year, FDA approvals are showing a much deeper decline of 19.8%.
Global regulatory activity has fallen slightly, partially due to a decline in pandemic activity, and U.S. FDA approvals of drugs and biologics are at their lowest levels in five years.
As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year.
A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances.
Only three other years during the past three decades did the U.S. FDA approve more new molecular entities (NMEs) than the 50 cleared in 2021, a year that was plagued with numerous delayed decisions. There were 53 NME approvals in 1996 and 53 again in 2020. The record is held by 2018, which had 59 approvals.
In what is undeniably one of the busiest years for governmental agencies across the globe, 2021 churned out a 12% increase in regulatory news over the previous record year of 2020.
A busy regulatory environment globally throughout most of 2021 has translated into more than 15% of all actions taken relating to the COVID-19 pandemic, yet only one product has been approved in the U.S. for the SARS-CoV-2 virus.
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
Global regulatory activity in 2021 has risen by 25% over this time last year, but the proportion of the activity associated with COVID-19 has dropped in recent months.
