PMDA Japan Approval Analysis FY 2020-22

Japan is one of the largest pharmaceutical market in the world. The COVID-19 impact, an ageing population and increasing chronic disease cases have drawn the attention of the Japanese government to the healthcare sector. Observing the difficulties faced in developing vaccines to combat the COVID-19 pandemic, Japan has given top priority to the research of novel drugs and vaccines.

The branded drug market in Japan experienced significant developments and transformations from 2020 to 2022. Over the years, the Pharmaceuticals and Medical Devices Agency (PMDA), has been actively involved in accelerating the approval timelines for new drugs and medical devices.

As per reports, in the fiscal year 2020–2022, PMDA approved approximately 148 novel drugs across various therapeutic categories. These new drug approvals provided patients with access to advanced treatment options and contributed to addressing unmet medical needs.

Pharmaceutical companies, including global players like Novartis, Pfizer, Sanofi and Takeda received the majority of PMDA approvals for the innovative drugs.

1) Novartis Pharma KK : Overall, Novartis obtained approval for seven drugs across different therapeutic areas:
• Immunology; Pulmonary and Respiratory Disease -2
• Immunology; Nervous System Disease– 2
• Cardiology- 1
• Hematology; Oncology -1
• Oncology– 1

The novel drugs Entresto, Scemblix and Tabrecta are the medications authorised for use in the therapeutic fields of cardiology, hematology; oncology and oncology respectively. Atectura and Enerzair were approved in the therapeutic category of immunology; pulmonary and respiratory disease, while Kesimpta and Mayzent were approved in the therapeutic category of immunology; nervous system disease.

According to reports, Novartis blockbuster drugs Entresto and Kesimpta showed strong performance and generated sales of USD 4,644 million and USD 1,092 million respectively in FY 2022. The PMDA approved Kesimpta on March 23, 2021. It is the first B-cell targeted therapy that can be self-administered subcutaneously at home to treat multiple sclerosis. Strong launch uptake, rising demand and its approval in almost 80 countries were the main drivers of the drug's increased sales. On June 29, 2020, Enteresto received approval for the treatment of patients with chronic heart failure. The reasons for its growth in the past two years may include continued strong demand and an increase in patient share across all markets.

2) Pfizer Japan Inc : Pfizer got PMDA approval across the therapeutic categories of :
• Infection & Infectious Disease – 3
• Cardiovascular Disease -1
• Congenital and Hereditary Disease; Dermatology -1
• Endocrinology; Musculoskeletal Disease -1
• Nervous System Disease -1

3) Sanofi KK : Sanofi received PMDA approval across :
• Congenital and Hereditary Disease -2
• Hematology-2
• Cardiovascular Disease; Oncology -1
• Endocrinology -1
• Infection & Infectious Disease – 1

4) Takeda Pharmaceutical : Along with Novartis, Pfizer and Sanofi, Takeda also obtained PMDA authorization for seven drugs:
• Infection & Infectious Disease-2
• Oncology-2
• Cardiovascular Disease: Congenital and Hereditary Disease-1
• Digestive System Disease- 1
• Nervous System Disease- 1

The other giant players, like Bayer Yakuhin and MSD KK, received the second-highest PMDA drug approval with six approvals each, while AstraZeneca and Chugai Pharma received the third-highest PMDA drug approval with five approvals apiece.

In the years between 2020 and 2022, PMDA Japan authorised innovative medications in 47 therapeutic categories. The highest number of approvals were given in the therapeutic areas of infection and infectious disease (17 approvals), oncology (16 approvals) and nervous system disease (11 approvals).

The treatment fields related to immunology; pulmonary and respiratory diseases, nutrition and metabolic disease, nervous system disease; oncology, endocrinology; musculoskeletal disorders, etc. received the fewest approvals.