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Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
March 14, 2003
Our STN: BL 103471/1039
Donald Gay
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Dear Mr. Gay:
Your request to supplement your biologics license application for
Interferon beta-1b (Betaseron®) to revise the Clinical Studies
section to include data from two studies conducted in patients with
secondary progressive multiple sclerosis (MS), to update the Adverse
Reactions and Warnings sections to include new safety information,
and to provide a Medication Guide, has been approved.
We acknowledge your written agreements to provide additional
information as described in your letters of May 10, 2002 and March
14, 2003, as outlined below:
- To provide reports and analyses of adverse events cited in the
package insert that were observed in the post-marketing
experience with Interferon-beta-1b, as well as other adverse
events of interest. A final report will be submitted to FDA by
July 12, 2003.
- To conduct a pregnancy registry study to prospectively record
and analyze pregnancy outcomes in 300 pregnant women with MS
exposed to Interferon beta-1b at the time of conception or
during the first trimester of pregnancy. This information will
be used to assess the potential risk to the mother, fetus and/or
live born infant. The final protocol will be submitted to FDA by
September 15, 2003. Patient accrual will be completed by March
31, 2008, the study will be completed by March 31, 2009, and a
final study report submitted to FDA by October 31, 2009.
- To provide validation information for the MxA neutralization
assay for antibodies to Interferon beta-1b, including validation
information regarding cutoff, intra-assay, inter-assay, and
inter-operator precision, sensitivity (limit of detection and
limit of quantification), specificity, and robustness. The
revised validation information, excluding serum stability
studies, will be submitted to FDA by May 15, 2003.
- To validate the stability of serum samples. In accordance with
the International Conference on Harmonisation (ICH), Q2A,
“Text on Validation of Analytical Procedures,” and Q2B,
“Validation of Analytical Procedures: Methodology,” the
serum samples will be placed on stability for eighteen months.
The interim analysis data will be submitted to FDA by December
31, 2003, and the validation information will be submitted to
FDA by May 15, 2004.
Pursuant to 21 CFR Part 208, FDA has determined that this product
poses a serious and significant public health concern requiring the
distribution of a Medication Guide. Distribution of a Medication
Guide is necessary for safe and effective use of this product. FDA
has determined that Interferon beta-1b is a product for which
patient labeling could help prevent serious adverse effects and
inform the patient of serious risks relative to benefit that could
affect their decisions to use, or continue to use, the product. See
21 CFR 208.1. FDA hereby approves the Medication Guide you submitted
March 14, 2003. Please note that the Medication Guide must be
printed in a minimum of ten point high text, as described in 21 CFR
208.20. In accordance with 21 CFR 208, you are responsible for
ensuring that this Medication Guide is available for every patient
who is dispensed a prescription for this product. In addition, you
are responsible for ensuring that the label of each container or
package includes a prominent and conspicuous instruction to
authorized dispensers to provide a Medication Guide to each patient
to whom the drug is dispensed, and states how the Medication Guide
is provided.
Please submit all final printed labeling at the time of use and
include implementation information on FDA Form 356h. Please provide
a PDF-format electronic copy as well as original paper copies (ten
for circulars and five for other labels). In addition, you may wish
to submit draft copies of the proposed introductory advertising and
promotional labeling with an FDA Form 2253 to the Center for
Biologics Evaluation and Research, Advertising and Promotional
Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD
20852-1448. Final printed advertising and promotional labeling
should be submitted at the time of initial dissemination,
accompanied by an FDA form 2253.
All promotional claims must by consistent with and not contrary
to approved labeling. No comparative promotional claim or claim of
superiority over other products should be made unless data to
support such claims are submitted to and approved by the Center for
Biologics Evaluation and Research.
This information will be included in your biologics license
application file.
Sincerely yours,
--- signature ---
Karen D. Weiss, M.D.
Director
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 3/20/2003
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Date created: September 25, 2003 |
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