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Nonprescription Orlistat GlaxoSmithKline Consumer Healthcare, Ltd New Drug Application (21-887) Joint Nonprescription Drugs Advisory Committee and Endocrinologic.

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Presentation on theme: "Nonprescription Orlistat GlaxoSmithKline Consumer Healthcare, Ltd New Drug Application (21-887) Joint Nonprescription Drugs Advisory Committee and Endocrinologic."— Presentation transcript:

1 Nonprescription Orlistat GlaxoSmithKline Consumer Healthcare, Ltd New Drug Application (21-887) Joint Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Bethesda, Maryland January 23, 2006 Julie Golden, M.D. Division of Metabolic and Endocrine Products Joint Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Bethesda, Maryland January 23, 2006 Julie Golden, M.D. Division of Metabolic and Endocrine Products Center for Drug Evaluation and Research

2 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 2 Outline Background Studies reviewed Efficacy considerations Safety considerations Conclusions Background Studies reviewed Efficacy considerations Safety considerations Conclusions

3 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 3 BackgroundBackground

4 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 4 Definitions: Overweight and Obesity Normal weight: BMI 18.5 – 24.9 kg/m² Overweight: BMI 25 – 29.9 kg/m² Obese: BMI > 30 kg/m² Morbidly obese: BMI > 40 kg/m² For this application: –Low overweight: BMI 25 – < 28 kg/m² –High overweight: BMI 28 – 29.9 kg/m² Normal weight: BMI 18.5 – 24.9 kg/m² Overweight: BMI 25 – 29.9 kg/m² Obese: BMI > 30 kg/m² Morbidly obese: BMI > 40 kg/m² For this application: –Low overweight: BMI 25 – < 28 kg/m² –High overweight: BMI 28 – 29.9 kg/m²

5 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 5 Orlistat Label Nonprescription vs. Prescription Nonprescription GSK Prescription Roche IndicationPromotion of weight loss when used along with a reduced calorie and low fat diet Obesity management including weight loss, weight maintenance, and prevention of weight regain when used in conjunction with a reduced- calorie diet Population“Overweight” (defined by the consumer) ≥ 18 yo Obese (BMI ≥ 30 kg/m² ) or BMI ≥ 27 kg/m² + other risk factors (e.g., HTN, DM, dyslipidemia) ≥ 18 yo; 12-16 yo Duration of useUp to 6 mosChronic (clinical data up to 4 yrs) Dose60 mg; 1-2 capsules TID120 mg TID

6 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 6 National Institutes of Health’s 2000 Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults Weight loss through diet and exercise –Obese –Overweight + comorbidities –High-risk waist circumference + comorbidities Pharmacotherapy –Only if lifestyle changes do not promote weight loss after 6 months Obese (≥ 30 kg/m²) BMI ≥ 27 kg/m² + comorbidities Weight loss through diet and exercise –Obese –Overweight + comorbidities –High-risk waist circumference + comorbidities Pharmacotherapy –Only if lifestyle changes do not promote weight loss after 6 months Obese (≥ 30 kg/m²) BMI ≥ 27 kg/m² + comorbidities

7 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 7 FDA’s Efficacy Criteria of Prescription Weight-Loss Drugs Mean % weight loss (drug group) – mean % weight loss (placebo group) ≥ 5%, OR The proportion of subjects who reach and maintain a loss ≥ 5% of baseline body weight is statistically greater in drug group vs. placebo group Mean % weight loss (drug group) – mean % weight loss (placebo group) ≥ 5%, OR The proportion of subjects who reach and maintain a loss ≥ 5% of baseline body weight is statistically greater in drug group vs. placebo group FDA 1996 Draft Guidance for the Clinical Evaluation of Weight-Control Drugs

8 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 8 How Orlistat Works Pharmacodynamic Effect –Orlistat 60 mg = ~25% fecal fat excretion –Orlistat 120 mg = ~30% fecal fat excretion Behavioral Modification Effect –Claim: patients favorably modify their diet due to GI side effects –Patients may also decrease drug use because of side effects The incidence of GI side effects is similar across different amounts of weight loss –Consume more fat: drug effect –Consume less fat: dietary/behavioral effect Pharmacodynamic Effect –Orlistat 60 mg = ~25% fecal fat excretion –Orlistat 120 mg = ~30% fecal fat excretion Behavioral Modification Effect –Claim: patients favorably modify their diet due to GI side effects –Patients may also decrease drug use because of side effects The incidence of GI side effects is similar across different amounts of weight loss –Consume more fat: drug effect –Consume less fat: dietary/behavioral effect

9 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 9 EfficacyEfficacy

10 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 10 Efficacy Studies 4 weeks 2 years 6 months 1 year Randomization Rx efficacy (weight maintenance) endpoint Rx efficacy (weight loss) endpoint NonRx efficacy endpoint 4 months NonRx efficacy endpoint Randomization BM14149, NM14161 (BMI 28-43 kg/m²) NM17247 (BMI 25-28 kg/m²) Placebo Orlistat 60 mg Orlistat 120 mg Placebo Orlistat 60 mg

11 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 11 Efficacy Studies StudyBM14149NM14161NM17247 N (ITT) PLA 236 60 mg 239 120 mg 241 PLA 212 60 mg 213 120 mg 210 PLA 184 60 mg 194 BMI 28-43 kg/m²30-43 kg/m²25-28 kg/m² Population High overweight and obese ObeseLow overweight Diet 30% fat (BMR x 1.3) - 600 kcal Minimum allowable: 1200 kcal/d 30% fat < 90 kg: 1200 kcal/d ≥ 90 kg: 1500 kcal/d 30% fat < 90 kg: 1200 kcal/d (F), 1400 kcal/d (M) ≥ 90 kg: 1400 kcal/d (F), 1600 kcal/d (M) Educational Program Regular counseling by dietician; food records returned monthly No counseling; self- instructional; videos; food records returned every 2 mos Self-instructional; dietary review; food records returned monthly

12 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 12 Completion Rates 6 months4 months Study BM14149 Study NM14161 Study NM17247 Placebo 76%73%72% Orlistat 60 82%79%78% Orlistat 120 83%80%NA

13 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 13 % of Subjects by BMI Group < 28 kg/m²28 - < 30 kg/m²≥ 30 kg/m² BM14149 N = 729 2.5%13.2%84.4% NM14161 N = 642 0%7.2%92.8% NM17247 N = 391 89.3%10.7%0%

14 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 14 Categorical Weight Loss Results – LOCF * * * * * p < 0.05 vs. placebo

15 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 15 Weight Change from Baseline – LOCF PLA60120 -20 -15 -10 -5 0 5 10 Wt change from baseline (kg) PLA60120PLA60 BM14149 Mth 6 NM14161 Mth 6 NM17247 Mth 4

16 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 16 Placebo-Subtracted Difference in Weight Change from Baseline (kg) and 95% CI – LOCF BM14149 High overweight/obese Month 6 NM14161 Obese Month 6 NM17247 Low overweight Month 4 Pla vs 60-1.8 (-2.6, -1.0)-2.4 (-3.2, -1.6)-1.1 (-1.7, -0.5) Pla vs 120-2.1 (-2.9, -1.3)-3.3 (-4.1, -2.5)

17 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 17 Weight Regain – 2 year data First year: hypocaloric diet; Second year: eucaloric diet Pooled studies: BM14149 and NM14161 –Orlistat or placebo for 2 years Additional study from Rx NDA, published in JAMA 1999 –Orlistat or placebo for 1 year –2 nd year: First year: hypocaloric diet; Second year: eucaloric diet Pooled studies: BM14149 and NM14161 –Orlistat or placebo for 2 years Additional study from Rx NDA, published in JAMA 1999 –Orlistat or placebo for 1 year –2 nd year: Placebo Orlistat Placebo Orlistat

18 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 18 Pooled Studies Weight Change Over 2 Years – Completers

19 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 19 Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat: A Randomized Controlled Trial Groups: –Placebo/placebo (n=133) –Orlistat 120/orlistat 120 (n=153) –Orlistat 120/orlistat 60 (n=152) –Orlistat 120/placebo (n=138) Behavior modification program: Dietitians, food diaries, counseling Davidson MH, et al. JAMA 1999; 281:235-242 Groups: –Placebo/placebo (n=133) –Orlistat 120/orlistat 120 (n=153) –Orlistat 120/orlistat 60 (n=152) –Orlistat 120/placebo (n=138) Behavior modification program: Dietitians, food diaries, counseling Davidson MH, et al. JAMA 1999; 281:235-242

20 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 20 – Mean Body Weight Change During 2 Years of Double-Blind Treatment – Completers Adapted from: Davidson, MH, et al. JAMA 1999;281:235-242

21 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 21 Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity 224 obese adults, 1 year, sibutramine Type of VisitNo. of visits/duration Diet/activity record review Drug + Intensive Therapy Primary care provider + weekly group meetings w/trained psychologist 30 visits/90 min + 8 visits/10-15 min yes Drug + Brief Therapy Primary care provider8 visits/10-15 minyes Intensive Therapy Weekly group meetings w/trained psychologist 30 visits/90 minyes Drug Alone Primary care provider8 visits/10-15 minno Wadden TA, et al. N Engl J Med 2005; 353:2111-20

22 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 22 Results of Lifestyle Modification Study – LOCF Weight % Subjects Changew/  5% loss Drug + Intensive Therapy-12.1 kg 73% Drug + Brief Therapy -7.5 kg 56% Intensive Therapy -6.7 kg 53% Drug -5.0 kg 42% Wadden TA, et al. N Engl J Med 2005; 353:2111-20 Weight % Subjects Changew/  5% loss Drug + Intensive Therapy-12.1 kg 73% Drug + Brief Therapy -7.5 kg 56% Intensive Therapy -6.7 kg 53% Drug -5.0 kg 42% Wadden TA, et al. N Engl J Med 2005; 353:2111-20

23 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 23 SafetySafety

24 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 24 Safety Database Studies from original Rx NDA (pooled): BM14149, NM14161, NM14302 New study: NM17247 Supportive studies: BM14150, Actual Use Trial, Consumer Use Study Post-marketing data: FDA Adverse Event Reporting System (AERS) Published literature Review of original Rx orlistat NDA Studies from original Rx NDA (pooled): BM14149, NM14161, NM14302 New study: NM17247 Supportive studies: BM14150, Actual Use Trial, Consumer Use Study Post-marketing data: FDA Adverse Event Reporting System (AERS) Published literature Review of original Rx orlistat NDA

25 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 25 Pooled Safety Studies StudyBM14149NM14161NM14302 N (ITT) PLA 237 60 mg 239 120 mg 242 PLA 212 60 mg 213 120 mg 210 PLA 185 30 mg 186 60 mg 171 120 mg 180 Design 4-week lead-in; 1- year weight loss; 1- year weight maintenance 6-month lead-in (dietary weight loss); 1-year weight maintenance Multivitamin No Yes

26 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 26 Safety Issues for Discussion Fat-soluble vitamins Drug interactions Pancreatitis Fat-soluble vitamins Drug interactions Pancreatitis

27 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 27 Study BM14149 (No MVI) Mean Change in Vitamin Concentrations Over Time * * * * * * * p < 0.001 vs. placebo

28 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 28 Study NM14161 (No MVI) Mean Change in Vitamin Concentrations Over Time * * * * † * p < 0.05 vs. placebo; † p < 0.10 vs. placebo

29 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 29 Study NM14302 (+ MVI) Mean Change in Vitamin Concentrations Over Time * * * * † * p < 0.05 vs. placebo; † p < 0.10 vs. placebo *

30 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 30 Frequency of 2 Consecutive Plasma Vitamin Concentrations Below the Limit of the Reference Range after 1 Year of Treatment PlaceboOrlistat 60Orlistat 120 Vitamin A0.5%1.0%1.8% Vitamin D3.6%3.8%7.7% Vitamin E0.5%4.1%3.9% Beta-carotene0.5%1.9%5.4% Rx NDA, 7 Phase 3 studies

31 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 31 Drug Interaction Warfarin No significant alteration of pharmacokinetics of warfarin Post-marketing, literature reports of prolonged prothrombin time Post-marketing reports of bleeding 7 of 14 patients on warfarin initially failed to identify that orlistat was inappropriate for their use No significant alteration of pharmacokinetics of warfarin Post-marketing, literature reports of prolonged prothrombin time Post-marketing reports of bleeding 7 of 14 patients on warfarin initially failed to identify that orlistat was inappropriate for their use

32 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 32 Drug Interaction Cyclosporine Weight gain is common after organ transplantation Orlistat-cyclosporine interaction study demonstrated decreased cyclosporine concentrations Post-marketing reports of decreased cyclosporine concentrations 2 cases of acute organ rejection: 1 mild, 1 moderate 1 of 2 patients on cyclosporine initially failed to identify that orlistat was inappropriate for use Weight gain is common after organ transplantation Orlistat-cyclosporine interaction study demonstrated decreased cyclosporine concentrations Post-marketing reports of decreased cyclosporine concentrations 2 cases of acute organ rejection: 1 mild, 1 moderate 1 of 2 patients on cyclosporine initially failed to identify that orlistat was inappropriate for use

33 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 33 PancreatitisPancreatitis FDA AERS Data –99 raw reports of “pancreatitis” for orlistat (30 US reports) –8 raw reports of “pancreatitis” for sibutramine (1 US report) No increase in incidence of pancreatitis in placebo-controlled trials of orlistat in patients treated for up to 4 years Review of issue is ongoing FDA AERS Data –99 raw reports of “pancreatitis” for orlistat (30 US reports) –8 raw reports of “pancreatitis” for sibutramine (1 US report) No increase in incidence of pancreatitis in placebo-controlled trials of orlistat in patients treated for up to 4 years Review of issue is ongoing

34 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 34 ConclusionsConclusions

35 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 35 Efficacy Conclusions Dose and Population Low overweight population at 4 months, orlistat 60 mg TID (Study NM17247) –Mean weight loss 1.1 kg –Primary Rx weight loss drug efficacy criterion (categorical weight loss) was not met Low overweight population at 4 months, orlistat 60 mg TID (Study NM17247) –Mean weight loss 1.1 kg –Primary Rx weight loss drug efficacy criterion (categorical weight loss) was not met

36 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 36 Efficacy Conclusions Duration and Lifestyle Pooled studies, obese and high overweight population (Study NM14161 and Study BM14149) –Greater overall weight loss was seen with intensive lifestyle intervention (BM14149) –Smaller drug treatment and dose effect was seen with intensive lifestyle intervention (BM14149) –More weight regained over 2 years with less intensive lifestyle intervention (NM14161) Pooled studies, obese and high overweight population (Study NM14161 and Study BM14149) –Greater overall weight loss was seen with intensive lifestyle intervention (BM14149) –Smaller drug treatment and dose effect was seen with intensive lifestyle intervention (BM14149) –More weight regained over 2 years with less intensive lifestyle intervention (NM14161)

37 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 37 Efficacy Conclusions Duration and Lifestyle Weight regain after discontinuation of orlistat (JAMA paper) Weight-loss drug more effective with lifestyle intervention (NEJM paper) Weight regain after discontinuation of orlistat (JAMA paper) Weight-loss drug more effective with lifestyle intervention (NEJM paper)

38 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 38 Safety Conclusions Fat-Soluble Vitamin Malabsorption A higher percentage of orlistat-treated subjects had 2 consecutive plasma fat-soluble vitamin concentrations below the lower limit after 1 year of treatment than placebo-treated subjects Prolonged orlistat use without appropriate supplementation may lead to clinically significant fat-soluble vitamin malabsorption –Bone –Warfarin A higher percentage of orlistat-treated subjects had 2 consecutive plasma fat-soluble vitamin concentrations below the lower limit after 1 year of treatment than placebo-treated subjects Prolonged orlistat use without appropriate supplementation may lead to clinically significant fat-soluble vitamin malabsorption –Bone –Warfarin

39 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 39 Safety Conclusions Important Drug Interactions Warfarin –Reports of prolonged PT and bleeding likely reflect vitamin K malabsorption and vitamin K insufficiency Cyclosporine –Reports of subtherapeutic cyclosporine concentrations, organ rejection (2), reflect decreased cyclosporine absorption when taken with orlistat Actual use trial indicates that labeled warnings may not be adequately communicated Warfarin –Reports of prolonged PT and bleeding likely reflect vitamin K malabsorption and vitamin K insufficiency Cyclosporine –Reports of subtherapeutic cyclosporine concentrations, organ rejection (2), reflect decreased cyclosporine absorption when taken with orlistat Actual use trial indicates that labeled warnings may not be adequately communicated

40 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 40 Safety Conclusions Pancreatitis: Unclear Association with Orlistat No evidence from clinical studies that orlistat increases the risk for pancreatitis Increased number of AERS reports of pancreatitis in users of orlistat Investigation ongoing No evidence from clinical studies that orlistat increases the risk for pancreatitis Increased number of AERS reports of pancreatitis in users of orlistat Investigation ongoing

41 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 41 Do you believe that the potential benefits of nonprescription orlistat outweigh the risks?

42 Joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 23, 2006 42 AcknowledgementsAcknowledgements DMEP Clinical Review Team –Eric Colman, M.D. –Mary Parks, M.D. Statistical Review Team –Joy Mele, M.S. –Todd Sahlroot, Ph.D. Office of Drug Safety –Joslyn Swann, Pharm.D. –Lanh Green, Pharm.D., M.P.H. –Cynthia Kornegay, Ph.D. Project Management –Patricia Madara DMEP Clinical Review Team –Eric Colman, M.D. –Mary Parks, M.D. Statistical Review Team –Joy Mele, M.S. –Todd Sahlroot, Ph.D. Office of Drug Safety –Joslyn Swann, Pharm.D. –Lanh Green, Pharm.D., M.P.H. –Cynthia Kornegay, Ph.D. Project Management –Patricia Madara

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