From: Cagungun, Nannette
Sent: Tuesday, August 14, 2012 5:38 PM
To: 'Terry Kraynyk'
Subject: Information Request: Varicella Zoster Immune Globulin (Human)
Our Reference: STN 125430/0
Attention: Mr. Terry Kraynyk
August 14, 2012
Dear Mr. Kraynyk:
We are reviewing your biologics license application for Varicella Zoster Immune Globulin (Human) submitted on June 29, 2012 for post-exposure prophylaxis of varicella in high-risk individuals. We have the following request for information:
1. On page 18 (Section 1.4) of the pharmacovigilance plan (PVP), you state that “(w)ith the exception of serum sickness, all of the reported serious ADRs were isolated cases and do not represent an increased safety risk to patients receiving VariZIG” though elsewhere in your submission (e.g., proposed package insert section 6.2), you indicate that there was only a single case of serum sickness. Can you please clarify the quantity and quality of reported serum sickness cases, as well as provide an assessment of the increased risk of serum sickness posed by VariZIG?
2. On page 18 (Section 1.4) of the PVP you state that regarding clinical trial ADRs, “(n)one of the cases were fatal” though elsewhere in your submission (e.g., most recent PSUR on page 23 in Section 10.6) you indicate that eight fatal cases were observed in clinical trials. Can you please clarify this apparent discrepancy?
Please submit your response to this information request as an amendment to this file by August 24, 2012 referencing the date of this request. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
If you have any questions, please contact me at (301) 827-6174.
Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
1401 Rockville Pike Rockville, MD 20852-1448
Tel: (301) 827 6174
Fax: (301) 827 2857
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