7. At this time the sponsor’s proposed application of routine risk minimisation activities would appear to be reasonable and therefore generally acceptable. Nevertheless, the ASA may need to be revised if additional ongoing safety concerns are included. Furthermore as per the Risk Management Plan (RMP) Questions and Answers (Version 1.3, October 2012) as found on the TGA website, these guidelines state: ‘The ASA should identify any differences between the EU-RMP and the local implementation of risk management activities, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU Summary of Product Characteristics (SmPC) and the proposed Australian Product Information (PI), and the reasons for the difference. This will allow the TGA to assess the appropriateness of the proposed RMP in the Australian environment.’ Consequently the sponsor should identify and provide reasons for any differences between the risk minimisation activities undertaken as reflected in the content of the EU The sponsor states: ‘The differences between the PI and the SmPC are minor and have no impact on the level of safety profile as described in the RMP and ASA. Therefore no change has been made to the ASA.’ This is not entirely satisfactory. Consequently it is recommended that the ASA should include a risk minimisation activities table, which compares the actual content and wording of the current EU SmPC and the proposed Australian PI & CMI for all of the specified ongoing safety concerns and missing information. This table should identify and provide reasons for any observed differences particularly where it appears the EU SmPC is more restrictive. The TGA can then validate the sponsor’s assertion that there are no material differences between the routine risk minimisation activities undertaken in Europe compared to Australia. An adequately revised ASA should be submitted for review before this application is approved.
Study 201051 was conducted at 35 centres in 7 countries (Austria, Bulgaria, Czech Republic, Hungary, Latvia, Portugal and Spain) between March 2011 and May 2012. The study design is summarised in Table 6 below. Table 6: Study 201051 design Ocular diagnosis and medical history were similar across the treatment groups. 60% of study participants were women and the age range was 19 to 85 years. The following table summarises the results. Table 7: Study 201051 results Safety No new safety issues were identified for this FDC. The safety profile is similar to that for the mono products administered concomitantly. Clinical evaluator’s recommendation The clinical evaluator would have no objection to the approval of Taptiqom (tafluprost 15 micrograms/mL and timolol [as maleate] 5 mg/mL) for the indication of: Taptiqom is indicated for the reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension when concomitant therapy is appropriate. Risk management plan Important identified risks, important potential risks and missing information are a combination of those for the mono products. Risk-benefit analysis Delegate’s considerations The FDC is more effective in reducing intraocular pressure than each of the two mono products alone and is non-inferior to concomitant use of the mono products. The FDC product does not pose any new safety concerns over those posed by concomitant use of the two mono products. Additional information required from sponsor prior to the Advisory Committee on Prescription Medicines (ACPM) meeting Update the overseas registration status. Provide the latest version of the EU Summary of Product Characteristics (SmPC) negotiated with the EMA. Provide the EMA evaluation report. Proposed action The Delegate had no reason to say, at this time, that the application for the FDC product Taptiqom should not be approved for registration.