January is historically the weakest month of the year for FDA approvals and 2021 is following that trend.

With only nine approvals tracked by BioWorld during the month, it falls short of the 12 approvals during the same month in 2020, and it is the lowest amount in a single month since January of 2019, which also recorded nine. In fact, each of the last four years had a monthly average of about 17 approvals. There were 203 FDA approvals in 2020.

New molecular entities (NMEs), however, are running about the same, with three approved in each of the last two Januarys. The four-year average is four NMEs approved per month. Aurinia Pharmaceuticals Inc.’s Lupkynis (voclosporin) for lupus nephritis, Merck & Co. Inc.’s Verquvo (vericiguat) for heart failure, and Viiv Healthcare Ltd.’s Vocabria/Cabenuva (cabotegravir/rilpivirine) for HIV all received the FDA’s blessing in January. There were 53 NMEs, including 49 therapeutics and four diagnostics, that were approved in 2020.

Regulatory data down

The 223 regulatory items tracked by BioWorld in January 2021 are in line with November (224) and October (225), but down from the 268 entries in December. Regulatory data in 2020 were 47% above what was seen in 2019 (2,498 vs. 1,698), with December being the most productive month of the year. Regulatory news includes global approvals or rejections for trials and marketing, as well as priority review, orphan drug and other pathway designations.

About 13% of regulatory entries in January were focused on COVID-19 vaccines and therapeutics, keeping pace with the 13% for all of 2020.

So far in February, there have been 81 regulatory items (17 pandemic-related) and nine FDA approvals, two of which are NMEs. There are currently 142 products awaiting FDA approval on BioWorld’s PDUFA date list, which includes some that are overdue.

Regulatory and approval data through mid-February can be found within BioWorld Snapshots.