Freedom of Information request (FOI 22/1060)
Published 17 January 2024
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24th November 2022
FOI 22/1060
Dear
Thank you for your email, dated 27 October 2022, in which you requested the Clinical Study Report (CSR) associated with NCT01287117 (ASTERIA 1_Q4881g_study) for “Xolair (omalizumab)”.
In response to your request, we are providing the core CSR for NCT01287117 (ASTERIA 1_Q4881g_study), submitted for the Xolair applications PLGB 00101/1170-1173. The documentation has been redacted under Section 40 (Personal information), Section 41 (Information given in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
Disclosure of information subject to Section 40 (Personal information) would be an
infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.
Section 41 (Information given in confidence) is an absolute exemption, and no consideration of the public interest is necessary, except to state that the release of this information withheld under this section of the FOI Act would be considered an actionable breach by the MHRA.
We have redacted some parts of the attached documentation under Section 43 (Commercial interests) of the FOI Act because the release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests. The exemption is to safeguard the commercially sensitive information/commercial enterprise. This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention.
We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within 2 months of the date you receive this response and addressed to: [email protected], quoting reference FOI 22/1060.
If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF.
Yours sincerely,
The FOI Licensing Team