Lifecycle management of orphan drugs approved in Japan

Table 2 Characteristics of additional indications in each disease area

Categories	1	2	3–1	3–2	4	6–1	6–2	Imaging agent	Anticancer	Anti-HIV	Vaccine	Blood product	Total
Total	6	15	17	2	6	13	19	1	66	14	9	5	173
No additional indication	1	8	10	1	5	4	15	0	36	12	9	4	105
With additional indication	5	7	7	1	1	9	4	1	30	2	0	1	68
NonOD → OD	3	4	6	0	1	5	3	0	11	1	0	0	34
OD → nonOD	2	2	0	1	0	2	1	0	13	1	0	1	23
OD → OD	0	1	1	0	0	2	0	1	6	0	0	0	11

The PMDA classifies drug categories as follows: 1: gastrointestinal, topical, and immunosuppression 2: cardiovascular, Parkinson's, and Alzheimer's; 3–1: central nervous system and peripheral nervous system (except for anesthetics), 3–2: anesthetic, ophthalmic and otic; 4: antibacterial, anti-parasitic, and anti-viral (except for HIV); 5: urogenital and anal; 6–1: respiratory, anti-allergy, and anti-inflammatory; 6–2: hormones and metabolic disease

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