While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.
The 149 drugs and biologics approved by the agency so far this year are tracking similarly to 2019, which had 148 by the end of September, months before the SARS-CoV-2 virus began to take hold.
Since the start of 2020, BioWorld has logged a total of 1,620 regulatory news items, including global approvals and pathway designations, as well as complete response letters and rejections. The 149 FDA approvals this year represent five abbreviated new drug applications (ANDAs), 21 biologics license applications (BLAs), 55 new drug applications (NDAs), 36 supplemental BLAs and 32 supplemental NDAs. The complete dataset also includes agency action resulting in 19 complete response letters.
Of the approvals, 37 are for new molecular entities (NMEs), and August was the busiest month with eight NMEs approved. Most months, the agency gave its blessing to anywhere from three to five NMEs.
With 191 items of regulatory news, August was the slowest month of the last five months, down from 217 in July, 250 in June, 221 in May and 201 in April, but it was above what was seen in each month of the first quarter. So far in September there have been 101 regulatory entries. Within the August regulatory data, there were 29 (15%) news items focused on therapeutics or vaccines for COVID-19. That compares to 37 (17%) in July and 37 (15%) in June.
The 14% of regulatory news related to COVID-19 consists of nine delays, 207 focused on therapeutics for the virus, and 18 focused on vaccines.
Regulatory data updated through mid-September and a listing of FDA approvals in 2020 can be found within BioWorld Snapshots.