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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting Summary - VARIZIG, August 13, 2012

Date: August 13, 2012
From: Nannette Cagungun CBER/OBRR/DBA, HFM-380
To: 125430/0
Subject: Filing of the Varicella Zoster Immune Globulin (Human) BLA


CBER Participants:
Nannette Cagungun
Karen Campbell
Christine Harman
Nisha Jain
Michael Kennedy
Erin McDowell
David Menschik
Margaret Norton
Evi Struble
Chiang Syin
Maria Luisa Virata-Theimer
Michael Vardon

Recommendation:Â The review committee did not identify any major deficiencies and unanimously agreed to file the BLA and grant it a priority review. Â The action due date is December 29, 2012.

Discussion:
Cangene submitted the BLA on June 29, 2012. They requested a priority review of the BLA. The product is approved in Canada where it is known as VariZig™ and is available in the United States under an investigational new drug application (IND) Expanded Access Protocol.

The product received an orphan designation and is therefore exempt from pediatric studies.

The applicant submitted the data of 2 conformance lots to the BLA. The CMC reviewers will meet with DMPQ and DPQ to discuss the lot release protocol and lot release testing plan. The lot release protocol will be similar to that for Cangene’s other hyperimmune globulin products and will only differ in potency for anti-varicella. Cangene expects to make -(b)(4)- VariZig lot every two years.

Team Bio inspected the Winnipeg, Canada facility in May 2012. Â DMPQ will most likely recommend a waiver of the pre-licensure inspection pending the verification of information in the submission and provided the manufacturing process is the same.

The review committee agreed not to present this BLA to the Blood Products Advisory Committee (BPAC). The Chair will prepare the waiver request.