Vaccines, Blood & Biologics

January 29, 2015 Approval Letter - Hizentra

January 29, 2015

BLS APPROVAL LETTER

Our STN: BL 125350/416

CSL Behring AG
Attention: Mr. Kevin D. White
CSL Behring LLC
1020 First Avenue
PO Box 61501
King of Prussia, PA 19406-0901

Dear Mr. White:

We have approved your request to supplement your biologics license application for Immune Globulin Subcutaneous (Human), 20% Liquid [Hizentra], for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older for 2-7 times a week dosing of Hizentra, and for revision of the dose adjustment factor when switching from intravenous immune globulin (IGIV) to Hizentra.

Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10-point font.

Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.

You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Advertising and Promotional Labeling Branch at the following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave
WO71-G112
Silver Spring, MD 20993-0002

You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.

PEDIATRIC REQUIREMENTS

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, 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 for the pediatric population of 0 to 2 years of age because necessary studies are impossible or highly impracticable, due to the rarity of primary immunodeficiency diagnosed in this age group.

This product is appropriately labeled for use in the pediatric population of 2 to 16 years of age for frequent dosing (2 to 7 times per week) regimen for this indication. Therefore, no additional studies are needed in this pediatric group.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely,

Paul D. Mintz, MD
Director
Division of Hematology Clinical Review
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Enclosure

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