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Clinical Review, February 24, 2017

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Clinical Review, February 24, 2017 Clinical Reviewer: Kathleen Hise STN: 125592 BLA Clinical Review Memorandum Application Type Original Biologics License Application STN 125592 CBER Received Date February 9, 2016 PDUFA Goal Date February 7, 2017 (Non-PDUFA product) Division / Office DVRPA/OVRR Priority Review (Yes/No) No Reviewer Name(s) Kathleen S. Hise, MD Review Completion Date / February 24, 2017 Stamped Date Supervisory Concurrence Roshan Ramanathan, MD, MPH Jeff Roberts, MD Applicant Merck Sharp & Dohme Corp. Established Name House Dust Mite (Dermatophagoides pteronyssinus and Dermatophagoides farinae) Allergen Extract (Proposed) Trade Name ODACTRA Pharmacologic Class Allergenic extract Formulation(s), including Tablet Adjuvants, etc. Dosage Form(s) and Sublingual Route(s) of Administration Dosing Regimen Once daily Indication(s) and Intended Odactra is an allergen extract Population(s) indicated as immunotherapy for house dust mite induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides pteronyssinus and Dermatophagoides farinae house dust mites, or skin testing to licensed house dust mite allergen extracts. The intended population is adults 18 through 65 years of age Orphan Designated (Yes/No) No Page i Clinical Reviewer: Kathleen Hise STN: 125592 TABLE OF CONTENTS GLOSSARY ....................................................................................................................... 1 1. EXECUTIVE SUMMARY ................................................................................................... 3 1.1 Demographic Information: Subgroup Demographics and Analysis Summary.................... 7 2. CLINICAL AND REGULATORY BACKGROUND ................................................................... 7 2.1 Disease or Health-Related Condition(s) Studied ................................................................ 7 2.2 Currently Available, Pharmacologically Unrelated Treatment(s)/Intervention(s) for the Proposed Indication(s) ........................................................................................................ 8 2.3 Safety and Efficacy of Pharmacologically Related Products .............................................. 8 2.4 Previous Human Experience with the Product (Including Foreign Experience) ................. 8 2.5 Summary of Pre- and Post-submission Regulatory Activity Related to the Submission .. 10 3. SUBMISSION QUALITY AND GOOD CLINICAL PRACTICES ............................................... 12 3.1 Submission Quality and Completeness ............................................................................ 12 3.2 Compliance With Good Clinical Practices And Submission Integrity ............................... 12 3.3 Financial Disclosures ........................................................................................................ 12 4. SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ........ 13 4.1 Chemistry, Manufacturing, and Controls .......................................................................... 13 4.2 Assay Validation ................................................................................................................ 13 4.3 Nonclinical Pharmacology/Toxicology .............................................................................. 13 4.4 Clinical Pharmacology....................................................................................................... 15 4.4.1 Mechanism of Action ............................................................................................... 15 4.5 Statistical ........................................................................................................................... 15 4.6 Pharmacovigilance ............................................................................................................ 15 5. SOURCES OF CLINICAL DATA AND OTHER INFORMATION CONSIDERED IN THE REVIEW ... 16 5.1 Review Strategy ................................................................................................................ 16 5.2 BLA/IND Documents That Serve as the Basis for the Clinical Review ............................. 16 5.3 Table of Studies/Clinical Trials .......................................................................................... 18 5.4 Literature Reviewed .......................................................................................................... 18 6. DISCUSSION OF INDIVIDUAL STUDIES/CLINICAL TRIALS ................................................. 19 6.1 Trial #1: Protocol P001, NCT01700192 ............................................................................ 19 6.1.1 Objectives (Primary, Secondary) ............................................................................. 20 6.1.2 Design Overview ..................................................................................................... 20 6.1.3 Population ................................................................................................................ 21 6.1.4 Study Treatments or Agents Mandated by the Protocol ......................................... 23 6.1.5 Directions for Use .................................................................................................... 24 6.1.6 Sites and Centers .................................................................................................... 24 6.1.7 Surveillance/Monitoring ........................................................................................... 24 6.1.8 Endpoints and Criteria for Study Success ............................................................... 25 6.1.9 Statistical Considerations & Statistical Analysis Plan ............................................. 26 6.1.10 Study Population and Disposition .......................................................................... 27 6.1.11 Efficacy Analyses .................................................................................................. 30 6.1.12 Safety Analyses ..................................................................................................... 38 6.1.13 Study Summary and Conclusions ......................................................................... 45 6.2 Trial #2 Protocol P015/MT-06, NCT01454544 ................................................................. 46 6.2.1 Objectives (Primary, Secondary) ............................................................................. 46 6.2.2 Design Overview ..................................................................................................... 46 6.2.3 Population ................................................................................................................ 47 6.2.4 Study Treatments or Agents Mandated by the Protocol ......................................... 49 Page ii Clinical Reviewer: Kathleen Hise STN: 125592 6.2.5 Directions for Use .................................................................................................... 49 6.2.6 Sites and Centers .................................................................................................... 49 6.2.7 Surveillance/Monitoring ........................................................................................... 49 6.2.8 Endpoints and Criteria for Study Success ............................................................... 50 6.2.9 Statistical Considerations & Statistical Analysis Plan ............................................. 51 6.2.10 Study Population and Disposition .......................................................................... 51 6.2.11 Efficacy Analyses .................................................................................................. 53 6.2.12 Safety Analyses ..................................................................................................... 57 6.2.13 Study Summary and Conclusions ......................................................................... 59 6.3 Trial #3 Protocol P003 ...................................................................................................... 60 6.3.1 Objectives (Primary, Secondary) ............................................................................. 60 6.3.2 Design Overview ..................................................................................................... 61 6.3.3 Population ................................................................................................................ 62 6.3.4 Study Treatments or Agents Mandated by the Protocol ......................................... 64 6.3.5 Directions for Use .................................................................................................... 64 6.3.6 Sites and Centers .................................................................................................... 65 6.3.7 Surveillance/Monitoring ........................................................................................... 65 6.3.8 Endpoints and Criteria for Study Success ............................................................... 65 6.3.9 Statistical Considerations & Statistical Analysis Plan ............................................. 66 6.3.10 Study Population and Disposition .......................................................................... 66 6.3.11 Efficacy Analyses .................................................................................................. 68 6.3.12 Safety Analyses ....................................................................................................
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