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.
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.
auspar-tafluprost-timolol-150728.docx