Record of Telephone Conversation - Cervarix, June 29, 2009

System Info - 99593  SHONE, DEANNA   15-Jul-2009 15:50:27  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  29-JUN-2009 03:32 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Advice requested from Sponsor regarding assignment of UNII codes

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:

  

From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com]
 Sent: Monday, June 29, 2009 3:32 PM
 To: Gemignani, Helen S
 Cc: Cynthia.A.D'Ambrosio@gsk.com; nicholas.perombelon@gskbio.com
 Subject: Assignment of UNII codes for Cervarix

Hi Helen,
 I'm writing to begin the process for requesting UNII codes for our HPV vaccine. Below is the written request which will also be submitted formally to the BLA. Please let me know if you need any additional information from us.
 Thanks,
 Matt
 We're writing to request assignment of UNII (unique ingredient identifier) codes for Human Papillomavirus [Types 16 and 18] Monophosphoryl Lipid A Vaccine, Adsorbed. It is our understanding that CBER will work with the Substance Registration System (SRS) staff to assign these codes based upon a series of characteristics (provided below). We further understand that the aim is to provide UNII codes within 30 days (preferably 60 days) before approval of the product, to allow us to complete the Structured Product Labeling (SPL) drug listing.
 The current UNII code for the active moiety should be applicable to this product:
 HUMAN PAPILLOMAVIRUS ANTIGEN = 23CVL7WF4J
 While current UNII codes for HUMAN PAPILLOMAVIRUS TYPE 16 CAPSID PROTEIN ANTIGEN, A (6LTE2DNX63) or HUMAN PAPILLOMAVIRUS TYPE 18 CAPSID PROTEIN ANTIGEN, A (J2D279PEM5) are available, we are not able to determine whether these may be the correct assignments for our vaccine components.
 Therefore, we are asking that you assess whether these existing UNII codes are appropriate, or assign a new UNII code for this unique vaccine expression vector system (Trichoplusia ni cells).
 Characteristics of Human Papillomavirus [Types 16 and 18] Monophosphoryl Lipid A Vaccine, Adsorbed:
•class of infectious agent: Virus
•parent organism: Human Papillomavirus
•strain description: Types 16 and 18
•antigen identification: L1 protein
•antigen characterization: Recombinant
•modification state: Inactive
•inactivation method: Not applicable
•agent: Not applicable
•host source-expression system: Trichoplusia ni cells

In addition, the following adjuvant component and excipient contained in our Human Papillomavirus [Types 16 and 18] Monophosphoryl Lipid A Vaccine, Adsorbed need UNII codes:
•3-O-desacyl-4’-monophosphoryl lipid A (MPL)
•sodium dihydrogen phosphate dihydrate
