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209089Orig1s000 209090Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209089Orig1s000 209090Orig1s000 CLINICAL REVIEW(S) CLINICAL REVIEW Application Type NDA (Rx to OTC switch) Application Number(s) 209-089 Xyzal Allergy 24 HR tablets 209-090 Xyzal Allergy 24 HR solution Priority or Standard Standard Submit Date(s) March 18, 2016 Received Date(s) March 31, 2016 PDUFA Goal Date January 31, 2017 Division / Office DPARP/ODE 2/OND Reviewer Name(s) Xu Wang, M.D., Ph.D. Review Completion Date December 9, 2016 Established Name Levocetirizine dihydrochloride Rx Trade Name Xyzal tablets/solution OTC Trade Name Xyzal Allergy 24HR tablets/solution Therapeutic Class Antihistamine Applicant UCB Inc. Formulation(s) tablets/solution Dosing Regimen ≥12 years: One tablet (5 mg) daily/10 mL solution (5 mg) daily; 1 6 – 11 years: /2 tablet (2.5 mg) daily/5 mL solution (2.5 mg) daily; 2 – 5 years: 2.5 mL solution (1.25 mg) daily Indication(s) Temporarily relieve these symptoms due to hay fever or other upper respiratory allergies: • running nose, • sneezing, • itchy, watering eyes, • itching of nose or throat Intended Population(s) Tablets: ≥6 years of age Solution: ≥2 years of age Template Version: March 6, 2009 Reference ID: 4025819 Clinical Review Xu Wang, M.D., Ph.D. NDA 209-089/NDA 209-090 Rx to OTC switch Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets/solution Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT .........................................4 1.1 Recommendation on Regulatory Action ............................................................. 4 1.2 Risk Benefit Assessment .................................................................................... 4 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 4 2.1 Product Information ............................................................................................ 4 2.2 Currently Available Treatments for Proposed Indications................................... 5 2.3 Availability of Proposed Active Ingredient in the United States .......................... 5 2.5 Summary of Presubmission Regulatory Activity Related to Submission ..............5 3 ETHICS AND GOOD CLINICAL PRACTICES.........................................................6 3.1 Submission Quality and Integrity ........................................................................ 6 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ........................................................................................................... 6 4.1 Chemistry Manufacturing and Controls .............................................................. 6 4.3 Preclinical Pharmacology/Toxicology ................................................................. 7 4.4 Clinical Pharmacology ........................................................................................ 7 5 SOURCES OF CLINICAL DATA............................................................................ 7 5.1 Tables of Studies/Clinical Trials ....................................................................... 8 5.2 Review Strategy ............................................................................................... 8 6 REVIEW OF EFFICACY ......................................................................................... 9 Efficacy Summary...................................................................................................... 9 6.1.4 Analysis of Primary Endpoint(s) .................................................................... 9 7 REVIEW OF SAFETY............................................................................................. 14 Safety Summary ........................................................................................................ 14 9 APPENDICES ........................................................................................................ 14 9.1 Literature Review/References .......................................................................... 14 9.2 Labeling Recommendations ............................................................................. 15 9.3 Advisory Committee Meeting............................................................................ 15 2 Reference ID: 4025819 Clinical Review Xu Wang, M.D., Ph.D. NDA 209-089/NDA 209-090 Rx to OTC switch Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets/solution Table of Tables Table 1: Overview of 14 randomized, placebo-controlled studies for allergic rhinitis............... 8 Table 2: Dose-ranging studies mean rT4SS change over treatment period ………………………..10 Table 3: Efficacy results in studies A268 (SAR) and A266 (PAR)……………….. ..................11 Table 4: Mean rT4SS change in pediatric study A303 (SAR)……………………………........ 12 Table 5: Mean rT4SS change in pediatric study A304 (PAR)............................................... 12 Table 6: MSC change in EEU study A379, Onset and duration of action………………...........14 3 Reference ID: 4025819 Clinical Review Xu Wang, M.D., Ph.D. NDA 209-089/NDA 209-090 Rx to OTC switch Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets/solution 1 Recommendations/Risk Benefit Assessment 1.1 Recommendation on Regulatory Action The Applicant proposes a partial Rx to OTC switch of Xyzal (levocetirizine dihydrochloride). Xyzal tablets (NDA 22-064) and Xyzal solution (NDA 22-157) were approved on 05/25/2007 and 01/28/2008, respectively, for the treatment of seasonal and perennial allergic rhinitis, and chronic idiopathic urticaria (CIU) in patients 6 years of age and older (Xyzal tablets/solution prescription labeling). On 02/24/2009, the Applicant submitted pediatric study reports, as requested in a pediatric Written Request, and on 08/24/2009 Xyzal was approved in pediatric patients 6 months to <6 years of age. The Applicant proposes an OTC switch for allergic rhinitis in patients 2 years of age and older. The proposed OTC labeling states that levocetirizine dihydrochloride (LCTZ) is “for temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ●running nose, ●sneezing, ●itchy, watering eyes, ●itching of nose or throat.” The proposed OTC dosing regimen is the same as that of the prescription drug Xyzal. For patients ≥12 years: One tablet (5 mg) daily/10 mL solution (5 mg) daily; 1 Fro patients 6 – 11 years: /2 tablet (2.5 mg) daily or 5 mL solution (2.5 mg) daily; For patients 2 – 5 years: 2.5 mL solution (1.25 mg) daily. The recommended action for this prescription (Rx) to over-the-counter (OTC) switch for Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets and solution is Approval. 1.2 Risk Benefit Assessment Allergic rhinitis is a well-established OTC indication in the U.S., and both oral medications and nasal sprays are available OTC to treat this condition. Dose selection and efficacy of the product for adults and children ≥ 2 years of age were established during the prescription approval process, and efficacy is not expected to be different in the OTC setting. Thus, the benefit provided by LCTZ is well established and prior precedents exist for consumer self-selection for treatment of allergic rhinitis using oral drugs (Zyrtec, Claritin, and Allegra) in the OTC setting. It would benefit the public to have an additional oral antihistamine readily available as a nonprescription drug product. The safety of LCTZ is supported by the clinical development program for the prescription Xyzal, as well as by the post-marketing experience. Thus, the risk benefit assessment supports approval of LCTZ tablets and solution for the proposed partial OTC switch. 2 Introduction and Regulatory Background 2.1 Product Information Levocetirizine dihydrochloride (LCTZ) is an oral histamine H1-receptor antagonist (antihistamine) and the active R-enantiomer of the approved racemate, cetirizine (Zyrtec). In the United States, prescription drug Xyzal tablets, NDA 22-064, was approved 05/25/2007 with pediatric studies deferred. On 01/28/2008 prescription drug Xyzal solution, NDA 22-157, was approved. On 01/24/2009 FDA issued a pediatric Written Request to NDAs 22-064 and 22-157. On 02/24/ 2009, study reports for the requested 4 Reference ID: 4025819 threeClinical pediatric Review studies were submitted and pediatric exclusivity was granted for both NDAs on August 25,Xu Wang,2009. M.D., Ph.D. NDA 209-089/NDA 209-090 Rx to OTC switch Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets/solution LCTZ tablets and solution have been registered in many countries worldwide, including as prescription drugs in 60 countries and OTC drugs in 12 countries. To date, there have been no market withdrawals for LCTZ in any country due to safety reasons. 2.2 Currently Available Treatments for Proposed Indications In addition to avoidance of allergens, antihistamines are the first-line treatment for symptoms of allergic rhinitis. Several antihistamines are currently marketed as OTC monograph drugs in the US, including first-generation agents such as brompheniramine, chlorpheniramine, diphenhydramine, and doxylamine. These products are indicated for the treatment of symptoms of “hay fever or other upper respiratory allergies” [21 CFR 341.72]. The first-generation antihistamines are characterized by sedation as an adverse effect. There are also antihistamines marketed OTC in the US that were initially approved as NDA products, such as clemastine, and the second-generation antihistamine, loratadine and loratadine/PSE. Loratadine and other second-generation antihistamines typically have
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