Product Approval Information
Date : |
Tuesday, January 22, 2008 |
|---|---|
From: |
Felice D’Agnillo (Scientific Lead), LBVB/DH/CBER, HFM-343 |
Through : |
Abdu Alayash, Chief, LBVB/DH/CBER, HFM-343 |
To : |
Nannette Cagungun, Regulatory Project Manager, CBER/DH, HFM-380 |
Sponsor : |
Lev Pharmaceuticals Inc |
Product |
C1 Inhibitor (human) or Cinryze™ |
STN# : |
125267/0 |
Subject : |
Review Decision |
Review Decision
A Complete Response (CR) letter will be issued to the sponsor. This decision is primarily based on unresolved inspectional issues that were outlined in FDA Form 483 and issued to the sponsor on December 7, 2007.
Background
This submission is an original BLA from Lev Pharmaceuticals for C1-esterase inhibitor or Cinryze™ for the treatment of patients with hereditary angioedema (HAE). The clinical studies that included treatment of acute HAE attacks (Part A) and prophylaxis (Part B) were conducted under IND -(b)(4)-. The BLA was received in CBER/DCC on July 30, 2007 and was assigned STN# 125267/0. This BLA has orphan drug designation and qualified for priority review with an Action Due Date of January 30, 2008. The BLA was officially filed on September 28, 2007. An amendment was submitted October 30, 2007 containing the prophylaxis study data and the manufacturing and comparability data for intermediates produced at ----------(b)(4)-----------------------. The sponsor also submitted an amendment on November 23, 2007 containing responses to CBER's information request dated November 7, 2007. FDA’s information request items were partially based on issues related to the sponsor’s October 30 amendment.
The pre-approval inspection of -(b)(4)------ and Sanquin was held November 26, 2007 to December 7, 2007. The sponsor was informed via a teleconference on December 20, 2007 that a CR letter would be issued on or prior to the Action Due Date on the basis of unresolved inspectional issues that include various equipment and process qualifications as well as the manufacturing of new conformance lots. The inspectional issues are expected to be resolved late March or early April.