Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA's and FDA's Views on Initial Dual-Therapy.

Background: A fixed dose combination (FDC) product containing two components can be authorized for the use in 3 conceptual scenarios (1) as substitution for a treatment regimen containing both components given separately (substitution therapy) or (2) as replacement for a treatment regimen where the patient currently receives one of the components (add-on therapy) or (3) initial treatment of patients naïve to both components (initial combination therapy).

Method: Trends in European Medicine Agency (EMA) and Food and Drug Administration (FDA) approvals of FDC products for the 3 scenarios were explored by comparing the therapeutic indications retrieved from the EMA and FDA websites for FDCs approved between January 2000 and April 2017 within 5 selected therapeutic areas: type 2 diabetes mellitus (T2DM), asthma, chronic obstructive pulmonary disease, hypertension, and human immunodeficiency virus (HIV) infection.

Result: Approval decisions between EMA and FDA were largely aligned for the substitution therapy and add-on therapy scenarios.