Date: July 23, 2012
From: Nannette Cagungun CBER/OBRR/DBA, HFM-380
Subject: Varicella Zoster Immune Globulin (Human) BLA
Maria Luisa Virata-Theimer
Evi Struble –absent
The review committee presented an update of their preliminary review of the BLA.
The BIMO and the clinical reviewers determined a need for a BIMO inspection and agreed that selected clinical sites under Study VZ- 009, an open-label expanded access treatment study that has a large number of vulnerable subjects, be inspected. The clinical reviewer also recommended inspection of the Canadian clinical site under Study VZ-006 because it purports to be an efficacy study and includes pregnant women. The BIMO reviewer said that inspecting the foreign site might present timing challenges because resource allocations might not become available until after September 2012. A decision regarding inspection assignments will be made by the filing date.
Both BIMO and clinical reviewers noted that they were able to identify and access datasets for the expanded access case report forms.
The OBE reviewer noted that the pharmacovigilance study plan was not submitted in the BLA. It has been requested and is anticipated to arrive this week
The Chair informed the review committee that additional reviewers have been assigned to review the CMC section of the BLA.
The clinical pharmacologist has not yet looked at the submission. He will inform the RPM and Chair if he identifies any issues with the submission.
The statistician did not provide any comments.
A new facility reviewer will be assigned to the BLA and the current reviewer will provide consult. Since Team Bio inspected the Winnipeg facility in May 2012, the facility inspection will most likely be waived.
We will request a consult from OVRR to look at the VZIG potency assay.
The review committee will need to decide if this BLA warrants a BPAC presentation. In addition, if the review committee recommends approval of this BLA, the Chair and the clinical reviewer will need to draft a press release at least 30 days before the action due date.
With regard to the applicant’s request for a priority review, the clinical reviewer was not in favor of granting a priority review because the product is currently available under the Investigational New Drug (IND) Application Expanded Access Protocol. He will discuss this further with his branch chief.
A decision regarding the applicant’s request for a priority review will be made by the filing meeting which is scheduled for August 13, 2012.