

Information Request Email, July 16, 2014 - Hyqvia




 

 
From: Ward-Peralta, Cherie
 Sent: Wednesday, July 16, 2014 10:49 AM
 To: 'OBrien, Susan'
 Cc: 'Blackshere, Angela L'
 Subject: RE: Information Request for BL 125402/0 - Please respond ASAP 

Importance: High

Hello Ms. O’Brien,

Please provide a clarification on the following question as soon as possible. 
This can be sent by email and followed up with an official response within your 
amendment.

On page 54/204 of the HyQvia Briefing Book, Section 4.7.1.1, paragraph 2, it 
states that “Thirteen subjects experienced 1 or more serious adverse event [sic] 
during Study 160603. Of the 18 total events, 4 were initiated during the IV 
treatment in EPOCH 1 and 14 initiated during HyQvia treatment in EPOCH 2…”

In the Final Study Report for Study 160603, 
  Table 14.3-63, Summary of Adverse Events Categorized by MedDRA Preferred Terms 
  in Study Epoch 2, it states that the total number of Serious AEs was 11. 
  Table 14-3-61 lists the 11 SAEs by Subject Number: respiratory failure, status 
  epilepticus, tonsillar hypertrophy, thrombosis, headache, adrenocortical 
  insufficiency acute, gastroenteritis, cervical dysplasia, grand mal 
  convulsion, petit mal epilepsy, back injury

If you have any questions or need to discuss, please contact me.

Thanks,

Cherie

From: Ward-Peralta, Cherie 
 Sent: Tuesday, July 15, 2014 2:21 PM 
 To: 'OBrien, Susan' 
 Cc: Blackshere, Angela L 
 Subject: RE: Information Request for BL 125402/0 

Dear Ms. Blackshere,

We accept your request to submit a response to this information request on July 
17, 2014. Please include a response in that amendment to the following question:

What is the explanation for reports in volunteer studies 161001 and 170901, part 
4, that rHuPH20 had no effect (a) in-line pressure vs. flow rate, (b) in-line 
pressure vs. cumulative volume infused curves, (c) total volume of IGSC 10% 
infused with and without rHuPH20 preadministration for both IGSC doses (0.3 g/kg 
and 0.6 g/kg), (d) maximum tolerated flow rate (300 mL/h), and (e) median time 
needed to complete an infusion.

If you have any questions, please contact me.

Sincerely,

Cherie Ward-Peralta, M.S. 
 Regulatory Project Manager 
 Office of Blood Research and Review 
 Center for Biologics Evaluation and Research 
 10903 New Hamphsire Ave 
 WO-71- 4204
 Silver Spring, MD 20993 
 Phone: 240-402-8447
 Email: cherie.ward-peralta@fda.hhs.gov 

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From: OBrien, Susan [mailto:susan_obrien@baxter.com] 
 Sent: Friday, July 11, 2014 6:56 PM 
 To: Thompson, Edward 
 Cc: Ward-Peralta, Cherie; Blackshere, Angela L 
 Subject: RE: Information Request for BL 125402/0 

Dear Mr. Thompson,

Baxter is requesting an extension so that we have the appropriate time to ensure 
a correct response. We anticipate that we can submit by July 17, 2014.

Thanks

Susi O'Brien
 Associate Director, Regulatory Affairs
 One Baxter Way
 Westlake Village, CA 91362
 ofc: 805-372-3226 (Tie Line (b)(4))
 cell: -----(b)(6)------ 

From: Thompson, Edward [mailto:Edward.Thompson@fda.hhs.gov] 
 Sent: Friday, July 11, 2014 5:59 AM 
 To: Blackshere, Angela L 
 Cc: OBrien, Susan; Ward-Peralta, Cherie 
 Subject: Information Request for BL 125402/0 

Dear Ms. Blackshere:

We are reviewing your biologics license application (BLA) dated June 30, 2011 
for Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase 
and have determined that the following information is necessary to continue the 
review. Please submit your response to the following item:

Please clarify why studies in PI subjects (160602, 160601 and 160603) were 
initiated before studies in human volunteers (170901 and 161001)

The review of this submission is on-going and issues may be added, expanded 
upon, or modified as we continue to review this submission. 

Please submit your response to this information request as an amendment to this 
file by July 14, 2014. 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.

The action due date for this file is September 12, 2014.

If you have any questions, please contact me at (240) 402-8443. 

Sincerely,

Edward Thompson
 Regulatory Project Manager
 FDA/CBER/OBRR/RPMS

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