While U.S. FDA approvals are down by 27% in 2022, the agency was busy throughout the month of September, clearing seven new molecular entities (NMEs), the most for any month this year.
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.
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
Following the FDA giving the green light to seven new medicines in December, it brought the approval total of new molecular entities (NMEs) in 2020 to 53, an amount that equals the number of new medicines that were approved in 1996 and ranking it second equal all-time just behind the 59 NMEs that were approved in 2018.
Recovering from a complete response letter (CRL) in 2018, Trevena Inc. resubmitted its NDA for oliceridine, branded Olinvyk. On Aug. 7, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. opioid and for patients whose alternative treatments are inadequate. The FDA has now approved a total of 34 new molecular entities (NMEs) so far this year. That total is well ahead of the 18 NMEs that were approved at this time in 2019 even though the FDA suggested back in May that it might have trouble meeting PDUFA dates due to the resources it needed to devote to the COVID-19 pandemic.
After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks third behind the record 59 new medicines the agency approved last year and 53 in 1996.