Diabetes drugs: Historical regulatory decisions over the past 17 years

Domenico Merante, Antonio Ceriello

Research output: Contribution to journalArticle

Abstract

Diabetes mellitus is a common chronic disease that is already pandemic, and hyperglycaemia plays a key role in the development of diabetes complications. In the last 1520 years, we have witnessed a dramatic improvement of the 'armamentarium' developed by the pharmaceutical industry for treating diabetes. The objective of this review is to examine cases of relevant differences for these compounds in terms of approval, rejections, withdrawals and different labelling, between the US FDA and the European Medicines Agency (EMA) that have occurred since 1994, which was the date of the US approval of metformin. Cited examples include troglitazone, vildagliptin, liraglutide and the class of thiazolidinediones (TZDs) or 'glitazones'. We looked at the labelling of TZDs and the different evaluative approaches for rosiglitazone performed by the FDA and EMA last year. The latest assessment on pioglitazone from both agencies is also included in this review.It is difficult to understand the reasoning behind different decisions in these two regions. They might relate to the approval itself, likely due to a different benefitrisk assessment approach, or to the use of different guidances or guidelines. Differences in timing are also notable between the regions, even when licensing applications are submitted at the same time in both the US and Europe. It is easy to understand the need for a prolonged assessment time for the approval of a drug when more data are required by a regulatory agency (e.g. specific race-related findings from phase I studies or safety data in a specific target population, such as the elderly); however, many delays are not related to such requests. In addition, we looked at the timing of withdrawals of some new diabetes medicines, which also sometimes vary between regions.These different assessments have a negative impact on patients with diabetes, in terms of finding their own medications if they travel or live abroad, understanding their use and ultimately feeling reassured by a worldwide consistent safety profile. Regulatory agencies should be aligned in their requirements to clearly guide manufacturers in the clinical development of future innovative medicines in order to improve the treatment of diseases such as diabetes that present on a very large and costly scale and are growing in prevalence. We would welcome in the new millennium, the harmonization of criteria for the assessment of experimental antidiabetic therapies and the timing of approvals and withdrawals, as well as a uniformed labelling of diabetes drugs from the FDA, EMA and from any other regulatory agency.

Original languageEnglish
Pages (from-to)285-291
Number of pages7
JournalPharmaceutical Medicine
Volume25
Issue number5
DOIs
Publication statusPublished - 2011

Fingerprint

Thiazolidinediones
rosiglitazone
pioglitazone
troglitazone
Drug Labeling
Pharmaceutical Preparations
Drug Approval
Safety
Investigational Therapies
Health Services Needs and Demand
Metformin
Drug Industry
Pandemics
Diabetes Complications
Licensure
Hypoglycemic Agents
Hyperglycemia
Diabetes Mellitus
Emotions
Chronic Disease

Keywords

  • Acarbose
  • Benefit-risk-assessment
  • Colesevelam
  • Dapagliflozin
  • Diabetes-mellitus
  • European-Medicines-Agency
  • Exenatide
  • Food-and-Drug-Administration
  • Glibenclamidemetformin
  • Glimepiride
  • Glipizidemetformin
  • Glucagon
  • Insulin
  • Insulin-aspart
  • Insulin-aspartinsulin- protamine-aspart
  • Insulin-detemir
  • Insulin-glargine
  • Insulin-glulisine
  • Insulin-lispro
  • Labelling
  • Linagliptin
  • Liraglutide
  • Metformin
  • Metforminpioglitazone
  • Miglitol
  • Nateglinide
  • Pharmaceutical-industry
  • Pioglitazone
  • Pioglitazoneglimepiride
  • Pramlintide
  • Product-approvals
  • Repaglinide
  • Rosiglitazone
  • Rosiglitazoneglimepiride
  • Rosiglitazonemetformin, use
  • Saxagliptin
  • Saxagliptinmetformin
  • Sitagliptin
  • Sitagliptinmetformin
  • Thiazolidinediones
  • Troglitazone
  • Vildagliptin
  • Vildagliptinmetformin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Diabetes drugs : Historical regulatory decisions over the past 17 years. / Merante, Domenico; Ceriello, Antonio.

In: Pharmaceutical Medicine, Vol. 25, No. 5, 2011, p. 285-291.

Research output: Contribution to journalArticle

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AB - Diabetes mellitus is a common chronic disease that is already pandemic, and hyperglycaemia plays a key role in the development of diabetes complications. In the last 1520 years, we have witnessed a dramatic improvement of the 'armamentarium' developed by the pharmaceutical industry for treating diabetes. The objective of this review is to examine cases of relevant differences for these compounds in terms of approval, rejections, withdrawals and different labelling, between the US FDA and the European Medicines Agency (EMA) that have occurred since 1994, which was the date of the US approval of metformin. Cited examples include troglitazone, vildagliptin, liraglutide and the class of thiazolidinediones (TZDs) or 'glitazones'. We looked at the labelling of TZDs and the different evaluative approaches for rosiglitazone performed by the FDA and EMA last year. The latest assessment on pioglitazone from both agencies is also included in this review.It is difficult to understand the reasoning behind different decisions in these two regions. They might relate to the approval itself, likely due to a different benefitrisk assessment approach, or to the use of different guidances or guidelines. Differences in timing are also notable between the regions, even when licensing applications are submitted at the same time in both the US and Europe. It is easy to understand the need for a prolonged assessment time for the approval of a drug when more data are required by a regulatory agency (e.g. specific race-related findings from phase I studies or safety data in a specific target population, such as the elderly); however, many delays are not related to such requests. In addition, we looked at the timing of withdrawals of some new diabetes medicines, which also sometimes vary between regions.These different assessments have a negative impact on patients with diabetes, in terms of finding their own medications if they travel or live abroad, understanding their use and ultimately feeling reassured by a worldwide consistent safety profile. Regulatory agencies should be aligned in their requirements to clearly guide manufacturers in the clinical development of future innovative medicines in order to improve the treatment of diseases such as diabetes that present on a very large and costly scale and are growing in prevalence. We would welcome in the new millennium, the harmonization of criteria for the assessment of experimental antidiabetic therapies and the timing of approvals and withdrawals, as well as a uniformed labelling of diabetes drugs from the FDA, EMA and from any other regulatory agency.

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KW - Dapagliflozin

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KW - Food-and-Drug-Administration

KW - Glibenclamidemetformin

KW - Glimepiride

KW - Glipizidemetformin

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KW - Insulin

KW - Insulin-aspart

KW - Insulin-aspartinsulin- protamine-aspart

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KW - Insulin-glargine

KW - Insulin-glulisine

KW - Insulin-lispro

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KW - Liraglutide

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