PeRC: Not indicated since this product has Orphan Designation
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Vaccines, Blood & Biologics
MEETING DATE April 16, 2009 2:30 pm
MEETING TYPE: Mid Cycle Meeting
FROM: Debbie Cordaro DBA, HFM-370
RE: STN 125335/0
APPLICANT: Instituto Bioclon
PRODUCT: Centruroides (Scorpion) Immune F(ab’)2 Intravenous (Equine)
ACTION DUE DATE: July 24, 2009
TO: STN 125335/0 File
Robert Fisher, Debbie Cordaro. Hon Sum Ko, Xue (Mary) Lin, Evi Struble, Doug Frazier, Pei Zhang, Nancy Waites, Lori Peters, Michael Brony, Robert Wesley, Alan Ou, Iftehar Mahmood, Nisha Jain, Basil Golding
BPAC: This file will not be taken to the Blood Product Advisory Committee because it is not a new molecular entity. A waiver memo will be prepared.
Labeling: The draft content of labeling is planned to be sent to the PLR committee on June 26, 2009.
BIMO: University of Arizona IRB records will be reviewed prior to inspection. The results of the inspection were requested to be submitted by May 29, 2009.
Clinical: The clinical study data for efficacy is based on 15 subjects in a randomized controlled trial versus placebo. All other studies were open label. Efficacy will be based on a small study. The current indication is to “treat clinically important signs of envenomation.”
An information request for all case report forms (CRFs) will be sent.
OBE/Epidemiology: A Risk Evaluation and Mitigation Strategy (REMS) is not required. A pharmacovigilence plan has been submitted.
OBE/Biostatistics: Each patient will be evaluated at baseline and at one hour post treatment to determine if the level of toxin decreased. It was noted that the placebo group is older than the treatment group and was delayed in receiving treatment.
Mr. Frazier: Minor issues have been identified.
Dr. Fisher: Major deficiencies have been identified. There is no in-process control and process validation.
Dr. Zhang: There is a problem with the non-envelope virus clearance; removal by nanofiltration is not adequate.
APLB: The proprietary name review was completed on February 23, 2009.
Clinical Pharmacology: A PKstudy was not performed, instead Biclon submitted a publication. It is uncertain if data from a publication only is sufficient.
DMPQ:The majority of the information was received last week. The pre-license inspection is scheduled for June 20, 2009.