`
`Approval Package for:
`
`APPLICATION NUMBER:
`214187Orig1s000
`
`
`Trade Name:
`
`Epclusa oral pellets, 200/50 mg and 150/37.5 mg
`
`Generic or Proper
`Name:
`Sponsor:
`
`
`
`Sofosbuvir and velpatasvir
`
`Gilead Sciences, Inc.
`
`Approval Date:
`
`June 10, 2021
`
`Indication:
`
`EPCLUSA is a fixed-dose combination of sofosbuvir, a
`hepatitis C virus (HCV) nucleotide analog NS5B
`polymerase inhibitor, and velpatasvir, an HCV NS5A
`inhibitor, and is indicated for the treatment of adults and
`pediatric patients 3 years of age and older with chronic
`HCV genotype 1, 2, 3, 4, 5, or 6 infection:
`
`• without cirrhosis or with compensated cirrhosis
`• with decompensated cirrhosis for use in combination
` with ribavirin
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`214187Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`X
`
`X
`
`X
`X
`
`X
`
`X
`X
`X
`
`X
`
`
`
`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`214187Orig1s000
`
`
`APPROVAL LETTER
`
`
`
`NDA 214187
`
`
`
`NDA APPROVAL
`
`
`Gilead Sciences, Inc.
`Attention: John Lombardo
`Senior Manager, Regulatory Affairs
`333 Lakeside Drive
`Foster City, CA 94404
`
`
`Dear Mr. Lombardo:
`
`Please refer to your new drug application (NDA) dated December 15, 2020, received
`December 15, 2020, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Epclusa (sofosbuvir and velpatasvir)
`oral pellets, 200/50 mg and 150/37.5 mg.
`
`This new drug application provides for the use of Epclusa (sofosbuvir and velpatasvir),
`oral pellets, for the treatment of genotypes 1, 2, 3, 4, 5, or 6, chronic hepatitis C virus
`infection in pediatric patients who are at least 3 years of age.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
`Highlights of Prescribing Information. This waiver applies to all future supplements
`containing revised labeling unless we notify you otherwise.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Patient Package Insert, and Instructions for Use) as well as
`annual reportable changes not included in the enclosed labeling. Information on
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 4809414
`
`
`
`NDA 214187
`Page 2
`
`
`submitting SPL files using eLIST may be found in the guidance for industry SPL
`Standard for Content of Labeling Technical Qs and As.2
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND CONTAINER LABELING
`
`Submit final printed carton and container labeling that are identical to the enclosed
`carton and container labeling or carton and container labeling submitted on April 7,
`2021, as soon as they are available, but no more than 30 days after they are printed.
`Please submit these labeling electronically according to the guidance for industry
`Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
`Carton and Container Labeling for approved NDA 214187 Approval of this
`submission by FDA is not required before the labeling is used.
`
`DATING PERIOD
`
`Based on the stability data submitted to date, the expiry dating period for Epclusa
`(sofosbuvir and velpatasvir), oral pellets, shall be 24 months from the date of
`manufacture when stored below 30°C (86°F).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`We are waiving the pediatric study requirement from birth to less than 3 years because
`necessary studies are impossible or highly impracticable. This is because spontaneous
`HCV clearance is possible and very few patients in this age group require treatment.
`
`We note that you have fulfilled the pediatric study requirement for ages 3 years to less
`18 years for this application.
`
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4809414
`
`
`
`NDA 214187
`Page 3
`
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
`and the Prescribing Information, at the time of initial dissemination or publication,
`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
`Information and Instructions for completing the form can be found at FDA.gov.5
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Talia Lindheimer, Regulatory Project Manager, at
`301-960-3449.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Debra Birnkrant, MD
`Director
`Division of Antivirals
`Office of Infectious Diseases
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`Instructions for Use
`o
`• Carton and Container Labeling
`
`
`
`
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4809414
`
`
`
`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/
`------------------------------------------------------------
`
`POONAM MISHRA
`06/10/2021 11:39:06 AM
`For Division Director
`
`Reference ID: 4809414
`
`(
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