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213006Orig1s000 OTHER REVIEW(S) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 213006Orig1s000 OTHER REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Medical Policy PATIENT LABELING REVIEW Date: November 20, 2020 To: Nenita Crisostomo, RN Regulatory Project Manager Division of Urology, Obstetrics and Gynecology (DUOG) Through: LaShawn Griffiths, MSHS-PH, BSN, RN Associate Director for Patient Labeling Division of Medical Policy Programs (DMPP) Sharon Williams, MSN, BSN, RN Senior Patient Labeling Reviewer Division of Medical Policy Programs (DMPP) From: Lonice Carter, MS, RN, CNL Patient Labeling Reviewer Division of Medical Policy Programs (DMPP) Elvy Varghese, PharmD. Regulatory Review Officer Office of Prescription Drug Promotion (OPDP) Subject: Review of Patient Labeling: Patient Package Insert (PPI) Drug Name (established GEMTESA (vibegron) name): Dosage Form and Route: tablets, for oral use Application NDA 213006 Type/Number: Applicant: Urovant Sciences GmbH (Urovant) Reference ID: 4705052 1 INTRODUCTION On December 26, 2019, Urovant Sciences GmbH (Urovant) submitted for the Agency’s review an original New Drug Application (NDA)/New Molecular Entity 213006 for GEMTESA (vibegron) tablets, for oral use. The purpose of this NDA is to propose an indication for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. This collaborative review is written by the Division of Medical Policy Programs (DMPP) and the Office of Prescription Drug Promotion (OPDP) in response to a request by the Division of Urology, Obstetrics and Gynecology (DUOG) on February 4, 2020, for DMPP and OPDP to review the Applicant’s proposed Patient Package Insert (PPI) for GEMTESA (vibegron) tablets, for oral use. 2 MATERIAL REVIEWED • Draft GEMTESA (vibegron) PPI received on December 26, 2019, revised by the Review Division throughout the review cycle, and received by DMPP and OPDP on November 12, 2020. • Draft GEMTESA (vibegron) Prescribing Information (PI) received on December 26, 2019, revised by the Review Division throughout the review cycle, and received by DMPP and OPDP on November 12, 2020. 3 REVIEW METHODS To enhance patient comprehension, materials should be written at a 6th to 8th grade reading level, and have a reading ease score of at least 60%. A reading ease score of 60% corresponds to an 8th grade reading level. Additionally, in 2008 the American Society of Consultant Pharmacists Foundation (ASCP) in collaboration with the American Foundation for the Blind (AFB) published Guidelines for Prescription Labeling and Consumer Medication Information for People with Vision Loss. The ASCP and AFB recommended using fonts such as Verdana, Arial or APHont to make medical information more accessible for patients with vision loss. We reformatted the PPI document using the Arial font, size 10. In our collaborative review of the PPI we: • simplified wording and clarified concepts where possible • ensured that the PPI is consistent with the Prescribing Information (PI) • removed unnecessary or redundant information • ensured that the PPI is free of promotional language or suggested revisions to ensure that it is free of promotional language • ensured that the PPI meets the criteria as specified in FDA’s Guidance for Useful Written Consumer Medication Information (published July 2006) Reference ID: 4705052 4 CONCLUSIONS The PPI is acceptable with our recommended changes. 5 RECOMMENDATIONS • Please send these comments to the Applicant and copy DMPP and OPDP on the correspondence. • Our collaborative review of the PPI is appended to this memorandum. Consult DMPP and OPDP regarding any additional revisions made to the PI to determine if corresponding revisions need to be made to the PPI. Please let us know if you have any questions. 4 Pages of Draft Labeling have been Wtihheld in Full as b4 (CCI/TS) immediately following this page Reference ID: 4705052 Signature Page 1 of 1 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ LONICE J CARTER 11/20/2020 10:26:23 AM ELVY M VARGHESE 11/20/2020 10:40:24 AM SHARON W WILLIAMS 11/20/2020 10:41:45 AM LASHAWN M GRIFFITHS 11/20/2020 11:07:00 AM Reference ID: 4705052 FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research Office of Prescription Drug Promotion ****Pre-decisional Agency Information**** Memorandum Date: November 18, 2020 To: T D. Chang, Clinical Reviewer, M.D. Division of Urology, Obstetrics, and Gynecology (DUOG) Nenita Crisostomo, RN Senior Regulatory Health Project Manager, DUOG From: Elvy Varghese, PharmD. Regulatory Review Officer Office of Prescription Drug Promotion (OPDP) CC: Matthew Falter, PharmD Team Leader, OPDP Subject: OPDP Labeling Comments for GEMTESA® (vibegron) tablets, for oral use NDA: 213006 In response to DUOG’s consult request dated February 4, 2020, OPDP has reviewed the proposed product labeling (PI) and patient package insert (PPI) for the original NDA submission for GEMTESA® (vibegron) tablets, for oral use (Gemtesa). Labeling: OPDP’s comments on the proposed labeling are based on the draft labeling received by electronic mail from DUOG (Nenita Crisostomo) on November 10, 2020 and are provided below. A combined OPDP and Division of Medical Policy Programs (DMPP) review will be completed, and comments on the proposed PPI will be sent under separate cover. Thank you for your consult. If you have any questions, please contact Elvy Varghese at (240) 402-0080 or [email protected]. 20 Pages of Draft Labeling have been Wtihheld in Full as 1 b4 (CCI/TS) immediately following this page Reference ID: 4703494 Signature Page 1 of 1 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ ELVY M VARGHESE 11/18/2020 09:46:58 AM Reference ID: 4703494 Clinical Inspection Smnmary NDA213006 Clinical Inspection Summary Date October 8, 2020 From Ling Yang, M.D., Ph.D., FAAFP Min Lu, M.D., M.P.H., Team Leader Kassa Ayalew, M.D., M.P.H., Branch Chief Good Clinical Practice Assessment Branch (GCPAB) Division ofClinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) To Debuene Chang, M.D., Clinical Reviewer Mark Hirsch, M.D., Clinical Team Leader Nenita Crisostomo, Regulato1y Project Manager Division ofUrolo!ZV, Obstetrics and Gvnecolo12:v (DUOG) NDA # 213006 Applicant Urovant Sciences GmbH Dru2 Gemtesa (vibe12:ron) NME (Yes/No) Yes Review Priority Standard Proposed Indication(s) Treatment ofoveractive bladder with symptoms ofurge urinary incontinence, urgency, and urinary frequency Consultation Request Date Febrna1y 03, 2020 Summary Goal Date October 23, 2020 Action Goal Date December 23, 2020 PDUFA Date December 26, 2020 I. OVERALL ASSESSMENT OF FINDINGS AND RECOMMENDATIONS Clinical data from Studies RVT-901-3003 and RVT-901-3004 were subinitted to the Agency in support ofthis New Drng Application (NDA) for Gemtesa (vibegron) 75 mg oral tablets for the proposed indication. Three clinical investigators (Cis): Drs. Robe1i Heller (Site 10-123), Keila Hoover (Site 10-133) and John Pinches III (Site 10-156) were selected for clinical inspections. The inspections verified the sponsor Urovant Sciences GmbH (Urovant) subinitted clinical data with source records at the CI sites. Based on the results ofthese CI inspections, Study RVT-901­ 3003 and RVT-901-3004 appear to have been conducted adequately, and the data generated by these sites and subinitted by the sponsor appear acceptable in suppo1i ofthe respective indication. II. BACKGROUND Urovant subinitted NDA 213006 for Gemtesa (vibegron) 75 mg oral tablet on 12/26/2019. Vibegron, a highly selective beta-3 adrenergic receptor agonist, is administered once daily for the treatment ofoveractive bladder (OAB) with symptoms ofurge urina1y incontinence (UUI), urgency, and urina1y frequency. The sponsor subinitted data from two phase 3 clinical studies: RVT-901-3003, a 12-week efficacy and safety study; and RVT-901-3004, a 40-week long te1m safety study, to suppo1i the approval ofthe NDA. Reference ID 4683195 Page 2 Clinical Inspection Summary NDA 213006 RVT-901-3003 Study RVT-901-3003 was a randomized, double-blind, placebo- and active [tolterodine extended release (ER)]-controlled multicenter study to evaluate the safety and efficacy of vibegron (RVT­ 901) in patients with symptoms of OAB. The primary study objective was to evaluate the efficacy of vibegron 75 mg compared to placebo in subjects with symptoms of OAB, specifically the frequency of micturitions and frequency of UUI episodes. The co-primary efficacy endpoints were change from baseline (CFB) at Week 12 in average number of 1) micturitions per 24 hours in all OAB subjects; and 2) UUI episodes per 24 hours in OAB Wet subjects. The study consisted of a Screening Period (1-5 weeks),
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