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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Major Amendment Justification Memo - Berinert - June 26, 2008

Date:Thursday, June 26, 2008
From:Felice D’Agnillo, LBVB/DH/CBER, HFM-343
Through:Abdu Alayash, Chief, LBVB/DH/CBER, HFM-343
Basil Golding, Director, DH/CBER, HFM-330
To:Nannette Cagungun, Regulatory Project Manager, CBER/DH, HFM-380
Sponsor:CSL Behring
Product:C1 Inhibitor (human)
STN#:125287/0
Subject:Classification as Major Amendment of CSL Behring’s submission to their Biologics License Application in response to FDA’s Information Request

SUMMARY

This memorandum summarizes the decision to classify CSL Behring’s June 20, 2008 submission to their biologics license application (BLA) for C1 esterase inhibitor as a Major Amendment.

CSL Behring indicated that they would submit the safety update on the ongoing extension study during the March 26, 2008 telecon between CBER and CSL Behring representatives. The submission reached CBER on June 20, 2008, within 3 months of the action due date of the BLA. This submission significant updated clinical information (4 volumes).  In addition to this submission, the sponsor submitted three other amendments (dated June 3, 2008, June 12, 2008 and June 17, 2008) that arrived at CBER within three months of the action due date. Together, these amendments provide substantial information on statistical analysis of clinical data, analytical testing and validation, clinical pharmacology, immunogenicity, and CMCs.

Due to the extensive amount of new information as described above, this submission qualifies as a major amendment to the original BLA. Therefore, an additional three (3) months will be added to the time by which we should complete our review. The action due date is now December 5, 2008.