FOI release

Freedom of Information request on Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL 35507/0204) (FOI 21/880)

Published 20 January 2022

18th August 2021

FOI 21/880

Dear

Thank you for your communication, dated 30 July 2021, in which you requested the information relating to Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL 35507/0204). Please find responses to your questions below.

• What studies were performed to show that Luforbec 100/6 micrograms per actuation pressurised inhalation solution (PL-03557-0204) performs the same as Fostair 100/6 micrograms per actuation pressurised inhalation solution when used with the AeroChamber Plus spacer?

In accordance with the requirements of CPMP/EWP/4151/00 Rev. 1 ‘Guideline on the Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease in adults and for use in the treatment of asthma in children and adolescents’, appropriate in vitro studies have demonstrated equivalence between the two products when used with the AeroChamber Plus spacer.

Pharmaceutical studies (including studies of fine particle mass with spacer use) were also presented in line with guideline EMEA/CHMP/QWP/49313/2005 Corr ‘Guideline on the pharmaceutical quality of inhalation and nasal products.’

Please find attached a copy of the Clinical Overview that was submitted with the application for the above product, which details the clinical studies conducted, for your information.

Confidential information has been redacted in this document, according to Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Section 41 is an absolute exemption and no consideration of the public interest is required. Section 43 is a conditional exemption, 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. In this case we have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity).

• We request a copy of the clinical assessment report and Public Assessment Report for Luforbec 100/6 micrograms per actuation pressurised inhalation solution.

Please find a link to the published Public Assessment Report below:

https://mhraproducts4853.blob.core.windows.net/docs/c290e94b3a148b35f1b20146d533aff0cb132554

The Public Assessment Report is based on the assessment reports generated during the procedure, with commercially confidential information removed. We are therefore exempting release of the clinical assessment report according to Section 21 of the FOI Act (Information accessible by other means). Exemption of release of information according to this section of the FOI Act requires no consideration of the public interest.

I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.

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 two months of the date you receive this response and addressed to: info@mhra.gov.uk.

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,

The FOI Licensing Team