A REGULATORY COMPARARISON OF NON-INSULIN DEPENDENT TYPE II DIABETES DRUG APPROVALS IN THE UNITED STATES AND EUROPEAN UNION

Author(s)

Sanchez DP, Rubinstein J, Rubinstein E, Sliman R, Daniel K, Ho YS
Context Matters, Inc., New York, NY, USA

OBJECTIVES: In 2012, Downing et al published a novel study in the NEJM that compared the speed of regulatory agencies between 2001-2010, which demonstrated the FDA’s relative quickness. This paper narrows the scope to new non-insulin dependent type II diabetes drugs approved by the EMA and FDA (using their respective websites) during 2005-2013, accounting for new drug approvals and legal updates to regulatory systems in a disease condition that has faced a plethora of regulatory challenges. METHODS: Unlike Downing, this study looks at the European Commission’s (EC) decision, instead of the Committee for Medical Products for Human Use’s (CHMP) recommendation. A Marketing Authorization is issued upon EC decision, making it analogous with the data captured surrounding the FDA’s approval process. Additionally this analysis looks at the date submitted to the FDA and EMA as well as the approval date. The data consists of 12 non-insulin dependent moieties approved between 2005 and 2013. RESULTS: Out of the 12 new treatments, 10 were approved first by the FDA (83%). Additionally, the FDA began reviews before the EMA with a median time of 126.5 days. The FDA also completed 8 of the 12 regulatory reviews faster than the EMA while beginning regulatory review first in each case. Three of the four regulatory decisions in which the FDA was slower were outliers in terms of approval time. Additionally, when looking at the median, the FDA approved these moieties 77 days faster than the EMA while Downing’s findings only showed a 44-day differential. This was expected because the analysis included the EC decision takes about 2 months on average.  CONCLUSIONS: After updating the data, restricting it to a particular subset of diabetes treatments, and altering the EMA regulatory endpoint, Downing et al’s findings not only still hold true, but become even more pronounced.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PDB152

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling

Disease

Diabetes/Endocrine/Metabolic Disorders

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