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Orlistat 60 mg

Orlistat 60 mg. Joint Meeting Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees January 23, 2006 Andrea Leonard-Segal, M.D. Acting Director Division of Nonprescription Clinical Evaluation. Center for Drug Evaluation and Research. Introduction.

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Orlistat 60 mg

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  1. Orlistat 60 mg Joint Meeting Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees January 23, 2006 Andrea Leonard-Segal, M.D. Acting Director Division of Nonprescription Clinical Evaluation Center for Drug Evaluation and Research

  2. Introduction • Historical approach to approving weight loss drugs: Rx and OTC • Few words about Obesity and Overweight • Regulatory history of Orlistat • Regulatory requirements for non-prescription marketing • Outline agenda

  3. Historical Approach toPrescription Weight Loss Drugs • FDA’s approach to approving Rx weight loss drugs • Mirrored treatment recommendations in National Institute of Health guidelines • Target populations for drug therapy • Obese: Body Mass Index (BMI) ≥ 30 kg/m2 • Overweight: BMI ≥ 27 kg/m2 + other risk factors for cardiovascular disease and mortality (e.g., hypertension, diabetes mellitus, dyslipidemia)

  4. Historical Approach toNonprescription Weight Loss Drugs • Approach to OTC weight loss drug availability guided by OTC Monograph • 1982 Advance Notice of Proposed Rulemaking • Published in Federal Register • Recognizes weight control as an OTC indication • Treatment indication not based upon BMI

  5. Obesity Associated Diseases • In addition to cardiovascular risk factors, NIH’s 2000 guidelines list non-cardiovascular conditions for which obese patients are at risk • Osteoarthritis • Gynecological abnormalities • Gallstones • Stress Incontinence

  6. Overweight as Risk Factor (BMI 25 – 29.9) • Medical literature is replete with articles demonstrating non-cardiovascular risks of being overweight and obese • Examples • End Stage Renal Disease • Hsu C et al: Body Mass Index and Risk for End Stage Renal Disease. Ann Intern Med 2006;144:21-28

  7. Overweight as Risk Factor (BMI 25 – 29.9) • Osteoarthritis • Felson DT, et al: Weight loss reduces the risk for symptomatic knee osteoarthritis in women. The Framingham Study. Ann Intern Med. 1992;116:535-9. • Manninen P, et al:Weight changes and the risk of knee osteoarthritis requiring arthroplasty.Ann Rheum Dis. 2004 Nov;63(11):1434-7 • Holmberg S, et al: Knee osteoarthritis and body mass index: a population-based case-control study.Scand J Rheumatol. 2005;34(1):59-64. • Arthritis → physical inactivity → increased risk for Cardiovascular Disease and Diabetes • For OA, a little weight loss helps

  8. Regulatory History of Orlistat

  9. Xenical® (Orlistat 120 mg) • Approved in 1999 as prescription product • Pancreatic lipase inhibitor for obesity management • Roche Laboratories • Dose • 120 mg TID • Take with fat-containing meal

  10. Xenical® (Orlistat 120 mg) • Indications • Obesity management including weight loss and maintenance when used with reduced calorie diet • Reduce risk for weight gain after prior weight loss

  11. Xenical® (Orlistat 120 mg) • Target population • BMI ≥ 30 kg/m2 • BMI ≥ 27 kg/m2 + other risk factors (e.g., hypertension, diabetes mellitus, dyslipidemia) • Duration of therapy • Not limited by labeling

  12. Xenical® (Orlistat 120 mg) • Pediatric Population • December, 2003 • Labeling updated to include efficacy and safety data for obese adolescents ages 12 – 16 years • No pediatric indication, per se

  13. Alli (Orlistat 60 mg) • NDA under consideration today for Rx to OTC switch • GlaxoSmithKline • 1 to 2 capsules with each fat-containing meal • Not to exceed 6 capsules daily • Indication • Promote weight loss in overweight adults when used along with a reduced calorie and low fat diet • Target population • Overweight adults ≥18 years • Duration of therapy • 6 months

  14. Regulatory Requirements for Nonprescription Marketing

  15. 1951 Durham Humphrey Amendment to the Food, Drug and Cosmetic Act • Formally differentiates Rx from Non Rx Drugs • 2 Criteria carve niche for Prescription Drugs: • Drug can be used safely only under supervision because of: • drug's toxicity or • other potentiality for harmful effect, or • method of its use, or • collateral measures necessary to its use • If drug approved as result of a NDA for use under professional supervision • Otherwise, the drug should be available without a prescription.

  16. Prescription to Nonprescription Switch Considerations • Does the product have: • Acceptable safety profile? • Low potential for misuse and abuse? • Reasonable therapeutic index of safety? • Can the condition to be treated be self-recognized? • When used under non-Rx conditions is the product safe and effective? • Do the benefits outweigh risks in OTC setting?

  17. Issue for Today Does Orlistat meet regulatory requirements for nonprescription marketing?

  18. Agenda 8:40 FDA: Hx Weight Loss Drugs / Monograph 9:20 GlaxoSmithKline 10:45 Break 11:15 FDA Safety and Efficacy Label Comprehension Study Actual Use Study 12:15 Lunch 1:15 Committee Discussion 1:30 Open Public Hearing 2:30 Committee Deliberations

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