Lorcaserin for Weight Loss: Insights Into US Food and Drug Administration Approval

Abstract

THE PREVALENCE OF OBESITY OR OVERWEIGHT IS 69% in the United States. 1 Flegal K.M. Carroll M.D. Kit B.K. Ogden C.L. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012; 307: 491-497 Crossref PubMed Scopus (4072) Google Scholar Excess weight is associated with a higher risk of mortality and development of lifestyle diseases, including diabetes mellitus, 2 Gautier A. Roussel R. Ducluzeau P.H. et al. Increases in waist circumference and weight as predictors of type 2 diabetes in individuals with impaired fasting glucose: Influence of baseline BMI: Data from the DESIR study. Diabetes Care. 2010; 33: 1850-1852 Crossref PubMed Scopus (39) Google Scholar coronary artery disease, 3 Flint A.J. Hu F.B. Glynn R.J. et al. Excess weight and the risk of incident coronary heart disease among men and women. Obesity (Silver Spring). 2010; 18: 377-383 Crossref PubMed Scopus (83) Google Scholar dyslipidemia, 4 Joshi A.V. Day D. Lubowski T.J. Ambegaonkar A. Relationship between obesity and cardiovascular risk factors: Findings from a multi-state screening project in the United States. Curr Med Res Opin. 2005; 21: 1755-1761 Crossref PubMed Scopus (33) Google Scholar and hypertension. 4 Joshi A.V. Day D. Lubowski T.J. Ambegaonkar A. Relationship between obesity and cardiovascular risk factors: Findings from a multi-state screening project in the United States. Curr Med Res Opin. 2005; 21: 1755-1761 Crossref PubMed Scopus (33) Google Scholar The economic consequences of obesity are staggering, as adults with a body mass index (BMI) >30 pay 42% more in health care costs compared with their normal-weight counterparts, accounting for $147 billion annually attributed to obesity alone. 5 Finkelstein E.A. Trogdon J.G. Cohen J.W. Dietz W. Annual medical spending attributable to obesity: Payer-and service-specific estimates. Health Aff (Millwood). 2009; 28: w822-w831 Crossref PubMed Scopus (1943) Google Scholar Anti-obesity drugs have been developed to fill the therapeutic gap between lifestyle modification and bariatric surgery. However, the regulatory history of anti-obesity drugs is tainted by US Food and Drug Administration (FDA) rejections of new drug applications and market withdrawals of approved drugs due to serious adverse events. In fact, no obesity drug had been approved by the FDA since orlistat in 1999, until the recent clearance of lorcaserin hydrochloride (Belviq; Arena Pharmaceuticals). L. E. Miller is president, Miller Scientific Consulting, Inc, Arden, NC.