An Analysis of FDA-approved Drugs for Inflammation and Autoimmune Diseases

The term 'inflammation' captures a variety of disease processes linked with the immune system. An analysis of US Food and Drug Administration (FDA)-approved nuclear molecular entities (NMEs) reveals notable trends in terms of acute and chronic inflammatory indications. The number of NMEs peaked during the 1990s and has since declined by more than 50%. Whereas pharmaceutical companies have dominated the field, biotechnology companies now receive half of new approvals and academia has a relatively large role in terms of pivotal first patents. Another notable trend is that the relative number of NMEs targeting allergy has been decreasing, whereas those targeting autoimmune indications is increasing. Unlike other indications, NMEs for inflammation tend towards nuclear receptors and cytokines, and a disproportionate number of biologics target cytokine pathways.