TY - JOUR

T1 - An analysis of the fixed-dose combinations authorized by the European Union, 2009-14: A Focus on benefit-risk and clinial development condition

AU - Sawicki-Wrzask, Dominik

AU - Thomsen, Mikael

AU - Bjerrum, Ole Jannik

PY - 2015

Y1 - 2015

N2 - Background: Apparent issues with the treatment and management of complex, chronic, and multifactorial diseases with monotherapies are becoming more prevalent, with a potential solution being fixed-dose combinations (FDCs). There is a certain stigma associated with FDCs, namely after the bans in the mid- to late 20th century; however, FDCs have proven useful in improving efficacy, reducing adverse effects, prolonging marketability, and producing new therapeutic entities. In addition to this, FDCs may be advantageous in increasing patient compliance and reducing off-label use.Methods: FDCs authorized by the European Union in the past 5 years were analyzed according to benefit-risk and clinical trial design.Results: An overall stable authorization of FDCs from 2009 to 2014 was observed, with most being developed to treat cardiac- and immune-related disorders.The aforementioned bans have led to stricter guidelines and regulations on FDCs; however, the examples presented demonstrate that the clinical guidelines from the European Medicines Agency are flexible within limits and may be altered given proper justification.Conclusion: With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs.

AB - Background: Apparent issues with the treatment and management of complex, chronic, and multifactorial diseases with monotherapies are becoming more prevalent, with a potential solution being fixed-dose combinations (FDCs). There is a certain stigma associated with FDCs, namely after the bans in the mid- to late 20th century; however, FDCs have proven useful in improving efficacy, reducing adverse effects, prolonging marketability, and producing new therapeutic entities. In addition to this, FDCs may be advantageous in increasing patient compliance and reducing off-label use.Methods: FDCs authorized by the European Union in the past 5 years were analyzed according to benefit-risk and clinical trial design.Results: An overall stable authorization of FDCs from 2009 to 2014 was observed, with most being developed to treat cardiac- and immune-related disorders.The aforementioned bans have led to stricter guidelines and regulations on FDCs; however, the examples presented demonstrate that the clinical guidelines from the European Medicines Agency are flexible within limits and may be altered given proper justification.Conclusion: With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs.

KW - Faculty of Health and Medical Sciences

KW - combination therapy,regulatory science,regulatory guidelines

U2 - 10.1177/2168479014567322

DO - 10.1177/2168479014567322

M3 - Journal article

VL - 49

SP - 553

EP - 559

JO - Therapeutic Innovation & Regulatory Science

JF - Therapeutic Innovation & Regulatory Science

SN - 2168-4790

IS - 4

ER -