CDER Novel Drug Approvals Set Record Pace in First Quarter

April 6, 2021 – The FDA’s Center for Drug Evaluation and Research (CDER) approved 14 new molecular entities (NMEs) in the first quarter—up from 11 in the same span in 2020. According to AgencyIQ, this is a record for any first quarter in FDA history.

Taken together with the 53 NMEs approved in 2020 (story here), the rate of approval of novel drugs has remained very high throughout the COVID-19 pandemic, despite the increased workload and earlier warnings from the FDA itself that review timelines might be delayed.

Of the 14 approvals in the first quarter, four were in oncology and six were indicated for rare diseases—proportions that are roughly in line with the five year average, according to AgencyIQ. Also in keeping with past approvals, nine of the drugs (64 percent) had received priority review, and four received accelerated approval. AgencyIQ reports that all but one of the 14 drugs were submitted after the COVID-19 public health emergency declaration.

The high pace of approvals by CDER was not replicated by the Center for Biologics Evaluation and Research (CBER), which has had to pivot to expedited review of, and issuing emergency use authorizations for, COVID-19 vaccines and therapies. CBER approved only one novel drug in the first quarter this year, down from three in 2020’s first quarter; and approved only six novel drugs in 2020, down from 22 the year before.

“The number of NMEs approved in the first quarter does not necessarily foretell a record year, and it is possible that a negative impact from the agency’s backlog of work, clinical trials that suffered delays during the pandemic, and inability to complete some facilities inspections may become more apparent as the year unfolds,” commented Jon Bigelow, Executive Director of the Coalition for Healthcare Communication. “Still, the high pace of approvals provides strong evidence that the CDER staff has stayed focused and has used its time efficiently, despite all of the distractions of the past year.”

There have been widespread concerns that the pace of reviews and approvals by CDER would drop off; some reviewers have been reassigned to help with review and approval of COVID-19 vaccines and drugs, and there have been delays in facilities inspections due to pandemic-related travel limitations. Going forward, a further issue—the impact on clinical trials from pandemic-related changes in trial protocols, a higher than usual number of participants dropping out for safety concerns, and so on—may affect new drug applications.

For now, however, CDER has maintained its pace with non-COVID-19 drug approvals. “This bodes well for American patients, who will have access to innovative pharmaceuticals, and to the healthcare communications industry,” noted Bigelow.