Full
Outline
To comprehensively and systematically describe the new molecular entity approvals in the United States, and analyze the trends of new drug development and approval.
Statistical analyses of innovation, expedited programs, and indications were conducted based on information of new molecular entities approved between 1985—2019 in the U. S. Food and Drug Administration (FDA) in the Drugs@FDA database.
There were totally 1 096 new molecular entities approved by FDA between 1985—2019, including 930 chemical and 166 biological products. The proportions of orphan drugs, first-in-class drugs, and drugs approved through priority review in biologics were higher than those in chemical drugs, and the number of biologics approved each year was increasing. The mean drug review time was 594 days, decreasing with year. The review time of biologics, orphan drugs, first-in-class drugs, and drugs approved through priority review was significantly shorter compared to other new molecular entities (P<0.01). The mean review time of antitumor drugs was only 268 days, the shortest among all new drugs within the study period. From 1985 to 2019, the focus of new drug development gradually shifted from the fields of cardiovascular system, digestive system, and infectious diseases to antitumor drugs.
The new drug review time has been shortened, and biologics, orphan drugs, and antitumor drugs has become new focus of drug development.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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