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 3rd, 2023)