ViiV Healthcare CompanyVOCABRIA® (cabotegravir) 30 mg tablets

NDA 212887 COMPLETE RESPONSE

ViiV Healthcare Company

Attention: Beth Austin, PhD

Senior Director, Global Regulatory Affairs 5 Moore Drive, P.O. Box 13398 Research Triangle Park, NC 27709

Dear Dr. Austin:

Please refer to your new drug application (NDA) dated April 29, 2019, received April 29, 2019, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for VOCABRIA® (cabotegravir) 30 mg tablets.

We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendation to address the issue.

PRODUCT QUALITY

We have identified deficiencies in the product quality information for CABENUVA® (cabotegravir extended release injectable suspension + rilpivirine extended release injectable suspension) 600 mg/900 mg co-pack NDA. As the approval of the VOCABRIA (cabotegravir) NDA is contingent on the approval of the CABENUVA NDA, the CABENUVA NDA deficiencies must be adequately addressed before this application can be approved.

PRESCRIBING INFORMATION

We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the PLR Requirements for Prescribing Information’ and Pregnancy and Lactation Labeling Final Rule? websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances.

1 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm08415 9.htm

2 http://www. fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm09330 7.htm

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If you revise labeling, use the SRPI checklist to ensure that the Prescribing Information conforms with format items in regulations and guidances. Your response must include updated content of labeling [21 CFR 314.50(!)(1)(i)] in structured product labeling (SPL) format as described at FDA.gov.?

To facilitate review of your submission, provide a highlighted or marked-up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should include annotations that support any proposed changes.

CARTON AND CONTAINER LABELING

Submit latest draft carton and container labeling based on your proposed revision dated December 18, 2019.

PROPRIETARY NAME

Please refer to correspondence dated, July 1, 2019 which addresses the proposed proprietary name, VOCABRIA. This name was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.

SAFETY UPDATE When you respond to the above deficiencies, include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b). The safety update should include data from all nonclinical and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level. (1) Describe in detail any significant changes or findings in the safety profile. (2) When assembling the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, incorporate new safety data as follows:

e Present new safety data from the studies/clinical trials for the proposed indication using the same format as in the original submission.

e Present tabulations of the new safety data combined with the original application data.

3 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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e Include tables that compare frequencies of adverse events in the original application with the retabulated frequencies described in the bullet above.

e For indications other than the proposed indication, provide separate tables for the frequencies of adverse events occurring in Clinical trials.

(3) Present a retabulation of the reasons for premature trial discontinuation by incorporating the drop-outs from the newly completed trials. Describe any new trends or patterns identified.

(4) Provide case report forms and narrative summaries for each patient who died during a Clinical trial or who did not complete a trial because of an adverse event. In addition, provide narrative summaries for serious adverse events.

(5) Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original application data.

(6) Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).

(7) Provide a summary of worldwide experience on the safety of this drug. Include an updated estimate of use for drug marketed in other countries.

(8) Provide English translations of current approved foreign labeling not previously submitted.

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under

21 CFR 314.65. You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

U.S. Food and Drug Administration

Silver Spring, MD 20993 www.fda.gov

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The drug product may not be legally marketed until you have been notified in writing that this application is approved.

If you have any questions, call LCDR Andrew Gentles, PharmD, BCPS AQ-ID, Regulatory Project Manager, at (240) 402-5708 or the mainline at (301) 796-1500.

Sincerely,

{See appended electronic signature page} John Farley, MD, MPH

Director (Acting)

Office of Infectious Diseases Center for Drug Evaluation and Research

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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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.

JOHN J FARLEY 12/19/2019 05:19:04 PM

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