FOI release

Freedom of Information request (FOI 22/857)

Published 17 January 2024

FOI 22/857

19th August 2022

Dear

Thank you for your information request dated 21 July 2022, where you asked the following question:

“I am emailing to ask as there been reported deaths. in the Givinostat trial related or unrelated.”

Please see the information requested below.

Two clinical trials have been conducted in the UK investigating Givinostat for the treatment of Duchenne Muscular Dystrophy, one of which has completed and the other is ongoing. No deaths, either related or unrelated to Givinostat, have been reported in either trial.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre