An analysis of the fixed-dose combinations authorized by the European Union, 2009-14: A Focus on benefit-risk and clinial development condition
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An analysis of the fixed-dose combinations authorized by the European Union, 2009-14: A Focus on benefit-risk and clinial development condition. / Sawicki-Wrzask, Dominik; Thomsen, Mikael ; Bjerrum, Ole Jannik.
I: Therapeutic Innovation & Regulatory Science, Bind 49, Nr. 4, 2015, s. 553-559.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 140298397