国際共同治験の現状と海外データの評価 - Pmda

1 2012 9 Pharmaceuticals & Medical Devices Agency (PMDA) 2012 9 Pharmaceuticals & Medical Devices Agency versionEnglish version 2 2012 9 Pharmaceuticals & Medical Devices Agency 3 ICH E5 2012 9 Pharmaceuticals & Medical Devices AgencyTrends of GCTs including Japan40 5 10 15 20 25 30 0 50 100 150 200 250 300 350 400 % of MRCTsNumbers of All CTNFY2007(Apr-Sep)FY2008(Oct-Mar)FY2009F Y2010FY2011(Apr-Sep)(Oct-Mar)(Apr-Sep)(O ct-Mar)(Apr-Sep)(Oct-Mar)(Apr-Sep)(Oct-M ar) 2012 9 Pharmaceuticals & Medical Devices AgencyGCTs or Bridging-based Drug Approval5FY2007FY2008FY2009FY2010FY20110 255075100125 Total Bridging GCTN umber of Approved DrugsYear0246810 % of GCT % of Bridging% 2012 9 Pharmaceuticals & Medical Devices AgencyGCT-based Drug Approval (1)6 Name of DrugIndicationApprovalTolterodineOveract ive bladder with symptoms of urge urinary incontinence, urgency, and frequencyApr.

2 2006 LosartanDiabetic nephropathy with proteinuriaand hypertension in patients with type 2 diabetesApr. 2006 TrastuzumabAdjuvant therapy for metastatic HER2-overexpressing breast cancerFeb. 2008 Insulin glulisineDiabetes mellitusApr. 2009 TadalafilPulmonary arterial hypertensionOct. 2009 Peramivir*Type A and Type B Influenza virus infectionJan. 2010 EverolimusMetastatic renal cell carcinomaJan. 2010 PanitumumabMetastatic colorectal carcinoma with wild-type KRAS tumorsApr. 2010 Travoprost/Timolol* renal cell carcinomaJul. 2010 Red: Asian Global Clinical Trial*: First Approval in the world 2012 9 Pharmaceuticals & Medical Devices AgencyGCT-based Drug Approval (2)7 Name of DrugIndicationApprovalLaninamivir*Type A and Type B Influenza virus infectionSep. 2010 NilotinibNewly diagnosed chronic myeloid leukemia in chronic phaseNov. 2010 DabigatranStroke and systemic embolism in patients with non-valvularatrialfibrillationJan.

3 2011 TrastuzumabMetastatic HER2-overexpressing gastric cancerMar. 2011 PramipexoleParkinson's diseaseApr. 2011 Edoxaban*Prevention of venous thromboembolismafter major orthopedic surgeryApr. 2011 DasatinibChronic myeloid leukemia (CML)Jun. 2011 IndacaterolChronic obstructive pulmonary disease ( copd ), including chronic bronchitis and/or 2011 LinagliptinType 2 diabetes mellitus (adjunctive to diet and exercise)Jul. 2011 Red: Asian Global Clinical Trial*: First Approval in the world 2012 9 Pharmaceuticals & Medical Devices AgencyGCT-based Drug Approval (3)8 Name of DrugIndicationApprovalGefitinibEGFR-Posi tive unresectableor metastatic non-small cell lung cancer (NSCLC)Nov. 2011 EverolimusProgressive neuroendocrinetumors of pancreatic origin (PNET)Dec. 2011 DenosumabBone complications in patients with multiple myeloma or solid tumourthat has spread to the bone.

4 Jan. 2012 AripiprazoleManic episodes associated with bipolar disorderJan. 2012 OlanzapineDepression episodes associated with bipolar disorderFeb. 2012 ExenatideType II diabetes mellitus (adjunctive to diet, exercise and treatment with SU)Mar. 2012 CrizotinibAnaplasticlymphoma kinase(ALK)-positive, advanced or metastatic non-small cell lung cancer (NSCLC)Mar. 2012 Budesonide/ FormoterolAsthma (where use of a combination of inhaled corticosteroid and long-acting 2 adrenoceptoragonist is appropriate) Jun. 2012 FormoterolChronic obstructive pulmonary disease ( copd )Jun. 2012 Red: Asian Global Clinical Trial*: First Approval in the world 2012 9 Pharmaceuticals & Medical Devices Agency 9 2012 9 Pharmaceuticals & Medical Devices Agency10 1 D2 5-HT1A 5-HT2A 24 1 2012 9 Pharmaceuticals & Medical Devices Agency 11 ,JSM 2012 Preparedbased on (Drug-Placebo)

5 Number of patientsYMRS difference by countryIndonesiaJapanAllMalaysiaPhilippi nesTaiwanChinaFAS YMRS Young Mania Rating Scale 2012 9 Pharmaceuticals & Medical Devices Agency 12 PK PPK YMRS 2012 9 Pharmaceuticals & Medical Devices Agency 13 23 1 2012 9 Pharmaceuticals & Medical Devices Agency 14 Phase I 50-300 mg (110, 150mg)Phase II 12W 1 2 :3 n=174 110mg, 150mg, Phase III 1-3Y: 1 2 : 3 n=18113 110mg, 150mg, Phase I 10-600 mg (50-400mg)BA Phase II 12W: 1 2.

6 10 n=502 50, 150, 300mg 0, 81, 315mg Phase II 4 Y, 4 n=361 150, 300mg 1 1 , 1 2 2012 9 Pharmaceuticals & Medical Devices Agency 15 (Yearly rate%)182( )133( )198( )Hazard ratio(95%CI) ( ) ( ) JapaneseN107111108 Subject-years145150151 Stroke/SEE(Yearly rate%)2( )1( )4( )Hazard ratio(95%CI) ( ) ( ) 2012 9 Pharmaceuticals & Medical Devices Agency 16110mg150mgWarfarinTotalN601560766022 Subject-years119001203911797 Major bleeding(Yearly rate%)318( )375( )396( )Hazard ratio(95%CI) ( ) ( ) JapaneseN107111108 Subject-years145150151 Major bleeding(Yearly rate%)8( )5( )5( )Hazard ratio(95%CI) ( ) ( ) 2012 9 Pharmaceuticals & Medical Devices Agency 17 2012 9 Pharmaceuticals & Medical Devices Agency 18 PT-INR 2012 9 Pharmaceuticals & Medical Devices Agency19 2 5.

7 000 1 110 mg 1 2 2012 9 Pharmaceuticals & Medical Devices Agency 202011 3 2011 6 2011 7 2011 8 RMP 2012 9 Pharmaceuticals & Medical Devices AgencyEU 21 2012 9 Pharmaceuticals & Medical Devices Agency22 2012 9 Pharmaceuticals & Medical Devices Agency 23 2012 9 Pharmaceuticals & Medical Devices Agency PK 24 2012 9 Pharmaceuticals & Medical Devices AgencyPK 25 2012 9 Pharmaceuticals & Medical Devices Agency 26

8 2012 9 Pharmaceuticals & Medical Devices Agency 27 CTD 2012 9 Pharmaceuticals & Medical Devices Agency 6 28 2012 9 Pharmaceuticals & Medical Devices Agency 1 100 29 2012 9 Pharmaceuticals & Medical Devices AgencyInformation30 PMDA PMDA DRUG Information E-mail.