2022 FDA New Drug Approvals Lowest in Six Years

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) gave the nod to 37 new drugs for clinical use last year, a low after the past five years. However, this number was buffered by a slate of approvals by the Center for Biologics Evaluation and Research (CBER), reflecting a growing push for biologics.

According to Asher Mullard, “Several noteworthy approvals showcased new target space, new clinical opportunities and untapped commercial potential. Eli Lilly’s tirzepatide, for example, is a peptidic drug that mimics two gut hormones — glucagon-like peptide 1 (GLP1) and glucose-dependent insulinotropic polypeptide (GIP) — to control blood sugar levels in patients with type 2 diabetes. Synthetic versions of GLP1 were first approved in 2005, but Lilly’s co-agonist agent is the first to mimic GIP as well.”

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(Source: Nature Reviews Drug Discovery, January 3^rd, 2023)