subjects and patients with IPF or pulmonary fibrosis, including 1098 patients assigned to receive pirfenidone at doses of 2,403 mg/day or higher. Due to its availability in other markets, postmarketing experience for pirfenidone is based on cumulative exposure of over 15,000 patient-years. Pirfenidone has been an approved drug for the treatment of IPF in other countries such as Japan since 2008. Pirfenidone has been available on a namedpatient basis on the SAS. Guidance There is no specific EMA guidance for the investigation of drugs for IPF. The FDA gave advice on the design of the additional Study PIPF-016. Contents of the clinical dossier The submission included the following clinical information: 6 clinical pharmacology studies, including 5 that provided pharmacokinetic data and a pharmacodynamics study on ECG effects: 1 population pharmacokinetic analysis 3 pivotal efficacy/safety studies: (PIPF004, PIPF006 and PIPF016) 2 ongoing long-term safety studies Pooled analyses, Post-Marketing Safety Update Reports (PSUR), Integrated Summary of Efficacy, and Integrated Summary of Safety. In addition the sponsor also provided: Clinical summaries of efficacy, safety and other clinical literature EMA and Canadian regulatory reports Evaluator’s comments on clinical data Overall the development program was comprehensively documented and the dossier well presented, although links to some data were not functional. The clinical evaluation was based on the submitted information from the sponsor. Other agency reports were also viewed for additional information. Paediatric data The submission did not include paediatric data as IPF occurs only in the adult population. Good clinical practice The study reports for the each study submitted addressed the principles laid down in the Declaration of Helsinki, in accordance with the ICH Harmonised Tripartite Guideline for Good Clinical Practice and in accordance with any other applicable regulatory requirements. Pharmacokinetics Studies providing pharmacokinetic data Summaries of the pharmacokinetic studies were provided. Table 4 shows the studies relating to each pharmacokinetic topic.
subjects and patients with IPF or pulmonary fibrosis, including 1098 patients assigned to receive pirfenidone at doses of 2,403 mg/day or higher. Due to its availability in other markets, postmarketing experience for pirfenidone is based on cumulative exposure of over 15,000 patient-years. Pirfenidone has been an approved drug for the treatment of IPF in other countries such as Japan since 2008. Pirfenidone has been available on a namedpatient basis on the SAS. Guidance There is no specific EMA guidance for the investigation of drugs for IPF. The FDA gave advice on the design of the additional Study PIPF-016. Contents of the clinical dossier The submission included the following clinical information: 6 clinical pharmacology studies, including 5 that provided pharmacokinetic data and a pharmacodynamics study on ECG effects: 1 population pharmacokinetic analysis 3 pivotal efficacy/safety studies: (PIPF004, PIPF006 and PIPF016) 2 ongoing long-term safety studies Pooled analyses, Post-Marketing Safety Update Reports (PSUR), Integrated Summary of Efficacy, and Integrated Summary of Safety. In addition the sponsor also provided: Clinical summaries of efficacy, safety and other clinical literature EMA and Canadian regulatory reports Evaluator’s comments on clinical data Overall the development program was comprehensively documented and the dossier well presented, although links to some data were not functional. The clinical evaluation was based on the submitted information from the sponsor. Other agency reports were also viewed for additional information. Paediatric data The submission did not include paediatric data as IPF occurs only in the adult population. Good clinical practice The study reports for the each study submitted addressed the principles laid down in the Declaration of Helsinki, in accordance with the ICH Harmonised Tripartite Guideline for Good Clinical Practice and in accordance with any other applicable regulatory requirements. Pharmacokinetics Studies providing pharmacokinetic data Summaries of the pharmacokinetic studies were provided. Table 4 shows the studies relating to each pharmacokinetic topic.
auspar-pirfenidone-160809.docx