Factors affecting the innovativeness of new drugs: Analysis of first-in-class drugs

Abstract Purpose: Analyzing how the US Food and Drug Administration (FDA) designates first-in-class drugs, which is an indicator of the innovativeness of new drugs, is fundamental to promoting innovative research in the pharmaceutical industry. In this study, we identify the factors that influence the approval of first-in-class drugs by the US FDA. Methods: Datasets of new drugs approved by the US FDA between 2010 and 2022 were constructed using the EvaluatePharma database and Cortellis Competitive Intelligence. Using the set of drugs (n = 484) approved by the US FDA, we performed logistics regression analyses to identify the factors associated with the innovativeness of the new molecular entities. Molecular type, orphan drug status, disease, pharmacological action, drug target, firm size, country of developer, and drug development strategy were used as independent variables in the analyses. In addition, we examined differences over time. Results: We identified statistically significant differences relating to antibody biologics, orphan drugs, oncology drugs, protein targets, self-originated or in-licensed strategy of US companies, and the acquisition strategy of non-US companies in the approval of first-in-class drugs. These effects differed in the two periods studied: after 2017 and before 2016. Conclusion: By identifying the factors that influence the innovativeness of new drugs, pharmaceutical companies can develop strategies for developing innovative new drugs, and policymakers can gain insights into how to promote innovation in the pharmaceutical industry.