FOI release

FOI re press release

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2024/00647

Received 23 October 2024

Published 22 November 2024

Request

On 8 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published a press release confirming that MHRA has approved elafibranor (Iqirvo) to treat adult patients with primary biliary cholangitis. I write to request access to the following information under Section 1(1) of the Freedom of Information Act 2000 (FOIA): 1. Please confirm whether elafibranor (Iqirvo) has been granted a conditional marketing authorisation (CMA) or a standard (full) marketing authorisation (MA). * In case it is a conditional approval, please provide the conditions associated with the MA. * In case it is full MA, please provide the scientific rationale, given that the EMA and US FDA has granted a CMA/ accelerated approval recently. * Please also provide details of any post-approval commitments that forms basis of the approval. 1. Please provide (i) the original version (as submitted by the applicant);and (ii) the final version (at the time of approval), of the clinical overview (Module 2.5) of the marketing authorisation application of elafibranor (Iqirvo). 1. Please provide correspondence (including questions and answers) exchanged between the applicant and MHRA including the final scientific assessment report related to the assessment of clinical benefit of elafibranor (Iqirvo). 1. Please confirm the current status of orphan designation of elafibranor (Iqirvo) in UK following the issuance of PLGB license, and provide the supporting data submitted by the applicant to support the orphan designation. Please respond within 20 working days pursuant to Section 10(1) FOIA. If you have any queries regarding this request (or require payment for complying with this request), please contact us as soon as possible.

Response

see attached

Documents

• Elafribranor -AR for GB Orphan Designation (003) 20 (redacted).11.24.pdf (9.0 MB)
• FOI2024-00647 redacted for publication.pdf (117.2 KB)
• Iqirvo Module 2.5 (Clinical Overview).pdf (26.0 MB)

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