|Meeting DATE:||18 November 2009|
|FROM:||Pauline Cottrell, DBA, HFM380|
|RE:||Meeting Summary on the Status of STN 125251/0|
|Attendees:||Pauline Cottrell, Timothy Lee, Hon-Sum Ko, Iftekhar Mahmood, Basil Golding, Jonathan Rose, Ele Ibarra-Pratt, and Nisha Jain|
|SPONSOR:||Octapharma Pharmazeutik Produktionsges m.b.H.|
|PRODUCT:||von Willebrand Factor/Coagulation Factor VIII Complex (Human)|
|Due Date:||4 December 2009|
|To:||File of STN 125251/0|
Dr. Jain asked about the decision for Octpharma to use the manual method for determing the potency for this product. Dr. Lee said that FDA had reqeusted additional Wilate lots for testing, and the results indicated that there is a better coorelation between VWF:RCo values derived from Octapharma’s manual method and CBER’s semi-automated method. Therefore, we suggest that Octapharma use the manual method to determine the potency of the final drug product.
Dr. Jain asked about potency testing for Factor VIII (FVIII) with regard to the label. Dr. Lee said CBER will not test FVIII as part of lot release but Octapharma agreed to include the ratio of VWF:RCo to FVIII activity as a final product release specification.
Dr. Jain asked Dr. Mahmood how the PK data evaluated by Octpaharma’s modified BCS method will be interpreted to use in the label for physician dosing.
Dr. Mahmood said that a correction factor of 1.5 will be used to reconcile the differences in concentrations by 2 analytical methods.
It was also determined that the proper name will be von Willebrand Factor/Coagulation Factor VIII Complex (Human) instead of Coagulation Factor VIII/von Willebrand Factor Complex (Human) for Wilate because the indication is for treatment of von Willebrand disease.
There was a discussion with regard to the Pharmacovigilance Plan (PVP) and if FDA should ask Octapharma to provide a detailed plan to assess GI bleeding, especially hemorrhages, to discern the temporality of the product’s use relative to these bleeds. This can be an active surveillance for two years and reported in its own section in future PSURs per Dr. Jonathan Rose’s review memo. Dr. Rose said that this could be reviewed either prior or after approval.
Dr. Jain said that she would discuss this with Dr. Rose tomorrow after she reviewed his memo and a determination will be made then.
Dr. Golding asked about immunogenicity of this product. Dr. Ko said that Octapharma has done and continues to do studies. The data so far does not raise concern for these patients.
It was determined that the term diluent will replace solvent in the PI and the use of Mix2Vial device is acceptable for use of a reconstituion device for this product. It is a 510K-cleared device.
- Revisions to the PI will include correlation between the modified BCS and manual method to resolve the PK in the label
- Use of diluent instead of solvent
- The Mix2Vial device is acceptable for use
- Resolution of the PVP