What trends in drug research and development does the FDA's approval of new drug standards represent in the past five years?

Author: small two

As we all know, the U.

As the vane of global drug regulatory agencies, the FDA has always been known for its high standards.

This article mainly introduces the FDA approved new drug model that has been sought after in China in recent years and the trend of new drug approval under the FDA's high standards.

505(b)(2)

In 1984, the U.

The 505(b)(2) application contains a complete safety and effectiveness research report, but at least part of the information comes from research conducted by non-applicants or that the applicant has no right to cite.

Data source: Yaozhi data; Yaozhi consulting and collation

In addition to the reduction in the number of approvals that may be caused by the impact of COVID-19 in 2020, the number of 505(b)(2) notifications has increased year by year in recent years.

It is worth noting that: in December 2019, the innovative drug levalamlodipine maleate tablets (trade name: CONJUPRI) independently developed by Sinopharm Group Ouyi Pharmaceutical Co.

CONJUPRI is a calcium channel blocker used to treat high blood pressure.

First in Class

First in Class is the first innovative drug, which can be indirectly understood as 505(b)(1).

Industry insiders have pointed out: "The essence of First in Clas is to take a road that has not been walked or passed by the predecessors.

Data source: Yaozhi data; Yaozhi consulting and collation

In 2020, some of the more representative first drugs such as Rukobia (fostemsavir) tablets, a new type of antiretroviral drug, are suitable for adults with HIV-1, and have tried multiple HIV before.

Rukobia's approval marks a new class of antiretroviral drugs that may benefit patients who have exhausted other HIV-1 treatment options.

1st US

1st US is Approval in the US Before Other Countries.

Data source: Yaozhi data; Yaozhi consulting and collation

FDA base drug

On August 6, 2020, the then President of the United States issued an executive order "on ensuring that essential medicines and medical countermeasures are produced in the United States".

FDA base drugs are the drugs most needed by patients in emergency medical institutions in the United States.

Data source: Yaozhi data, Yaozhi consultation and collation; Drugs@FDA