P324: Analysis of Drug Development Trends in Japan for FDA Accelerated Approvals
Poster Presenter
Toru Suzuki
Head, Regulatory and Development policy
Novartis Pharma Japan
Objectives
To assess the potential for an increase in the number of conditional approvals used in Japan for FDA accelerated approval products following Japanese regulatory changes in 2024.
Method
The study analyzed products granted Accelerated Approval by the FDA CDER between 2020 and March 2023, focusing on those also approved in Japan. Data were collected on characteristic of applicants, disease area, submission category, submission and approval dates, review periods, clinical data package
Results
The analysis included 27 products (indications) granted Accelerated Approval by the FDA and also approved in Japan. More than 70% of these products are from foreign-affiliated companies, and approximately 80% have the same applicant in both the U.S. and Japan. New Molecular Entities (NMEs) account for 63%, and anti-cancer drugs account for 81% of the products. The average gap in submission dates between the FDA and Japan is 244.1 days, and the average gap in approval dates is 261.1 days. The review period in Japan is an average of 8.0 months, compared to 7.3 months in the U.S. 68% of the products received priority review, with 79% being orphan drugs. Japanese data are included in the clinical data package for all products, with Multi-Regional Clinical Trial (MRCT) Phase II being the most common study conducted. Approximately 60% of the products are subject to all-case surveillance as part of post-marketing investigations.
Conclusion
The analysis suggests that the majority of FDA Accelerated Approval products with Japanese data have been granted standard approval with usual conditions, including all-case surveillance. This indicates that these products may not be significantly impacted by the partial revision of the 'Handling of Conditional Approval for Pharmaceuticals' in Japan.
