PMID- 32072578
OWN - NLM
STAT- MEDLINE
DCOM- 20210602
LR  - 20210602
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 54
IP  - 2
DP  - 2020 Mar
TI  - 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.
PG  - 297-302
LID - 10.1007/s43441-019-00057-7 [doi]
AB  - 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 naive 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. Discrepancies were found for the initial 
      combination therapy scenario. CONCLUSION: Since EMA and FDA rely on similar 
      conceptional models when approving FDCs, the reasons behind this general 
      disparity are not clear, but may be found in the lack of evidence from the 
      registration studies. Sponsors and health authorities should work collaboratively 
      on closing that gap.
FAU - Bjerrum, Ole Jannik
AU  - Bjerrum OJ
AD  - Department of Drug Design and Pharmacology and Copenhagen, Centre for Regulatory 
      Science (CORS), University of Copenhagen, Copenhagen, Denmark. ojb@sund.ku.dk.
FAU - Eichendorff, Sascha
AU  - Eichendorff S
AD  - Department of Regulatory Affairs, Novo Nordisk, Soeborg, Denmark.
FAU - Alkis, Nada Bassam
AU  - Alkis NB
AUID- ORCID: 0000-0001-6581-6914
AD  - Department of Drug Design and Pharmacology and Copenhagen, Centre for Regulatory 
      Science (CORS), University of Copenhagen, Copenhagen, Denmark.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200106
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
SB  - IM
MH  - *Diabetes Mellitus, Type 2
MH  - *Drug Approval
MH  - Humans
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - add-on therapy
OT  - prescription drug labeling
OT  - regulatory approval
OT  - regulatory science
OT  - substitution therapy
OT  - therapeutic indication
EDAT- 2020/02/20 06:00
MHDA- 2021/06/03 06:00
CRDT- 2020/02/20 06:00
PHST- 2018/11/17 00:00 [received]
PHST- 2019/02/15 00:00 [accepted]
PHST- 2020/02/20 06:00 [entrez]
PHST- 2020/02/20 06:00 [pubmed]
PHST- 2021/06/03 06:00 [medline]
AID - 10.1007/s43441-019-00057-7 [pii]
AID - 10.1007/s43441-019-00057-7 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2020 Mar;54(2):297-302. doi: 10.1007/s43441-019-00057-7. 
      Epub 2020 Jan 6.