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Center for Drug Evaluation and Research CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 125276Orig1s131 Trade Name: ACTEMRA Generic or Proper tocilizumab Name: Sponsor: Genentech, Inc Approval Date: March 4, 2021 Indications: Rheumatoid Arthritis (RA) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti- Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell- induced severe or life-threatening cytokine release syndrome. CENTER FOR DRUG EVALUATION AND RESEARCH 125276Orig1s131 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters Labeling X REMS Officer/Employee List X Multidiscipline Review(s) X Summary Review Office Director Cross Discipline Team Leader Clinical Non-Clinical Statistical Clinical Pharmacology Product Quality Review(s) Clinical Microbiology / Virology Review(s) Other Reviews Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125276Orig1s131 APPROVAL LETTER BLA 125276/S-131 SUPPLEMENT APPROVAL Genentech, Inc. 1 DNA Way, Bldg 45-1 South San Francisco, CA 94080-4990 Attention: Dhushy Thambipillai Regulatory Program Management Dear Ms. Thambipillai: Please refer to your supplemental biologics license application (sBLA), dated July 24, 2020, received July 24, 2020, and your amendments, submitted under section 351(a) of the Public Health Service Act for Actemra (Tocilizumab) for Intravenous Injection. We also refer to our approval letter dated March 4, 2021, which contained the following error: revision dates that were not updated in the Medication Guide and Instructions for Use. This replacement approval letter incorporates the correction of the error. The effective approval date will remain March 4, 2021, the date of the original approval letter. This supplemental biologics application provides for alignment of the common prescribing information for two routes of administration of Actemra by adding the labeling changes proposed for BLA 125472/S-044 Actemra SC for the new indication of slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 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 HIGHLIGHTS ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS Please note that we have previously granted a waiver of the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of Prescribing Information. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit, via the FDA automated drug registration and listing system (eLIST), the content of labeling Reference ID: 4757547 BLA 125276/S-131 Page 2 [21 CFR 601.14(b)] in structured product labeling (SPL) format, as described at FDA.gov,1 that is identical to the enclosed labeling (text for the Prescribing Information, Instructions for Use, and Medication Guide) and include the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements Information on 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. Also within 14 days, amend all pending supplemental applications that include labeling changes for this BLA, including pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 601.12(f)] in Microsoft Word format that includes the changes approved in this supplemental application, as well as annual reportable changes. To facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s). 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(s) in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because none of these criteria apply to your application, you are exempt from this requirement. 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 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm 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. 3 For the most recent version of a guidance, check the FDA guidance web page athttps://www.fda.gov/media/128163/download. U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov Reference ID: 4757547 BLA 125276/S-131 Page 3 As required under 21 CFR 601.12(f)(4), 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 BLA (in 21 CFR 600.80 and in 21 CFR 600.81). If you have any questions, call Elaine Sit, Regulatory Project Manager, at (301) 796- 5073. Sincerely, {See appended electronic signature page} Nikolay P. Nikolov, MD Director Division of Rheumatology and Transplant Medicine Office of Immunology and Inflammation Center for Drug Evaluation and Research ENCLOSURE(S): x Content of Labeling o Prescribing Information o Medication Guide o Instructions for Use 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: 4757547 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/ ------------------------------------------------------------ NIKOLAY P NIKOLOV 03/04/2021 12:00:00 AM Reference ID: 4757547 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125276Orig1s131 LABELING HIGHLIGHTS OF PRESCRIBING INFORMATION ACTEMRA can be used alone following discontinuation of glucocorticoids. These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA subcutaneous formulation is not intended for intravenous ACTEMRA. administration. ACTEMRA® (tocilizumab) injection, for intravenous or subcutaneous use Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) (2.3) Initial U.S. Approval: 2010 Recommended Adult Subcutaneous Dosage: The recommended dose of ACTEMRA for adult patients with SSc-ILD is 162 WARNING: RISK OF SERIOUS INFECTIONS mg given once every week as a subcutaneous injection. See full prescribing information for complete boxed warning. x Serious infections leading to hospitalization or death including Polyarticular Juvenile Idiopathic Arthritis (2.4) tuberculosis (TB), bacterial, invasive fungal, viral, and other Recommended Intravenous PJIA Dosage Every 4 Weeks opportunistic infections have occurred in patients receiving Patients less than 30 kg weight 10 mg per kg ACTEMRA. (5.1) Patients at or above 30 kg 8 mg per kg x If a serious infection develops, interrupt ACTEMRA until the weight infection is controlled. (5.1) x Perform test for latent TB; if positive, start treatment for TB prior to Recommended Subcutaneous PJIA Dosage starting ACTEMRA. (5.1) Patients less than 30 kg weight 162 mg once every three weeks x Monitor all patients for active TB during treatment, even if initial Patients at or above 30 kg 162 mg once
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