Record of Telephone Conversation, February 16, 2011 - Kedbumin

Submission Type: BLA    Submission ID: 125384/0    Office: OBRR
Product:
Albumin (Human)
Applicant:
Kedrion, S.p.A.
Telecon Date/Time: 16-Feb-2011 09:00 AM        Initiated by FDA? Yes
Telephone Number: -------(b)(4)--------
Communication Categorie(s):
1. Advice

Author: CRYSTAL ALLARD
Telecon Summary:
Discussion regarding Kedrion's request for a full PREA waiver
FDA Participants:
Crystal Allard, RAC
Laurence Landow, M.D.

Non-FDA Participants: 
Bruno Fiorentino, MD, Kedrion S.p.A.
-------(b)(6)------, Kedrion S.p.A.
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Telecon Body:

Kedrion requested a full PREA (Pediatric Research Equity Act) waiver in their BLA submission, but FDA has determined that Kedrion must complete a pediatric safety study  in pediatric patients aged 0 – 12 years. The study should be a randomized controlled trial with 100 subjects (50 in the study group and 50 in the control group) in total and should be completed no later than 36 months after approval of 125384/0.

The population should include similar numbers of subjects among the different age groups 0-2, 2-6, and 6-12.

Study milestones will be specified in the approval letter. Kedrion and FDA must agree on the protocol and timelines prior to approval.

FDA would like to review Kedrion’s draft protocol as soon as possible.  

Regarding postmarketing data for UMAN Albumin, Kedrion noted there are only minor CMC differences between the albumin product which Kedrion has marketed in Europe (UMAN Albumin) and the product they intend to market in the U.S. (Kedbumin). The differences are in the final product and are due to US manufacturing requirements. Kedrion will send an amendment to the BLA 125384/0 with more information explaining the differences.  

Though UMAN albumin has been licensed in Europe for 40 years, only postmarketing data from 2002 – 2010 were submitted to BL125384. This is because prior to 2002, the data were not collected or analyzed using meaningful standards and are not comparable to the standards applied to data collected now.

Kedrion will send the following information in a forthcoming amendment to 125384/0:
1.What method was used to collect the postmarketing data?
2.What pharmacovigilance tools were used to analyze the data?
3.What countries did the data come from?
