2020-2021 U.S. New Drug Approval Update Report

Between 2011 and 2021, the U.
S.
Centers for Drug Review (CDER) approved an average of about 41.
81 new drugs per year
.

In 2021, the FDA has completed a total of 4,828 drug and biologics marketing approvals, including 3,378 generic drug applications (ANDA), 224 biologics licenses (BLA), and 1,226 drug marketing authorizations (NDA), of which the first application (ORIG) That is, 100 new drugs, 21 biological preparations and 771 generic drugs were approved

01 Review of CDER's 2020 FDA approval

01 Review of CDER's 2020 FDA approval

Although the regulatory processes of drug regulatory agencies in various countries in the world vary greatly, the US FDA seems to be the first choice for the launch of innovative drugs
.

Of the 53 new drugs approved by the FDA in 2020, 40 (75%) were priority drugs approved for marketing in the United States

1.
CDER (2011 – 2021) Annual New Drug Approval Statistics

1.
CDER (2011 – 2021) Annual New Drug Approval Statistics

In 2020, CDER approved 53 new drugs
.

As shown, from 2011 to 2021, CDER approved an average of about 41.

Compared with previous years, the number of new drug approvals has increased significantly in the past five years
.

Figure 1: CDER (2011–2021) Annual New Drug Approvals

2.
New Drugs Approved by CDER in 2020

2.
New Drugs Approved by CDER in 2020

A total of 53 new drugs were approved by CDER in 2020.
The new drugs are listed below in alphabetical order by brand name
.

Artesunate (Artesunate), Ayvakit, Barhemsys, Blenrep, Byfavo, Cerianna, Danyelza, Detectnet, Dojolvi, Ebanga, Enspryng, Evrysdi, Ga 68 PSMA-11, Gavreto, Gemtesa, Imcivree, Inmazeb, Inqovi, Isturisa, Klisyri, Koselugo, Lampit, Margenza, Monjuvi, Nexletol, Nurtec ODT, Olinvyk, Ongentys, Orgovyx, Orladeyo, Oxlumo, Pemazyre, Pizensy, Qinlock, Retevmo, Rukobia, Sarclisa, Sogroya, Tabrecta, Tauvid, Tazverik, Tepezza, Trodelvy, Tukysa, Uplizna , Viltepso, Vyepti, Winlevi, Xeglyze, Zeposia, Zepzelca and Zokinvy
.

02 FDA approval in 2021

02 FDA approval in 2021

In 2021, the FDA has completed a total of 4,828 drug and biologics marketing approvals, including 3,378 generic drug applications (ANDA), 224 biologics licenses (BLA), and 1,226 drug marketing authorizations (NDA), of which the first application (ORIG) That is, 100 new drugs, 21 biological preparations and 771 generic drugs were approved
.

In 2021, the Center for Biologics Evaluation and Research (CBER) focused on recommending a new batch of BLA formulations (other than those used in blood banks) and BLA supplements that are expected to significantly improve public health (e.
g.
, for new/expanded indications) , new routes of administration, new dosage formulations and improved safety)
.

Among them, 13 new biologics licenses (BLAs), and 12 biolicense application supplementary products deserve attention

Table 1: 2021 Center for Biologics Evaluation and Research (CBER)

Approved Biological License Application (BLA)

In 2021, the US FDA approved a total of 50 new molecular entity drugs (NMEs)
.

Many of these products contain active moieties that were not previously approved by the FDA, either as single-ingredient drugs or as part of a combination product; these products provide important new treatments for patients

Table 2: 2021 Center for Drug Evaluation and Research (CDER) Approved New Molecular Entities (NMEs)

Note: The above is a list of new molecular entities and new therapeutic biological products approved by CDER in 2021
.

This list does not include vaccines, allergic products, blood and blood products, plasma derivatives, cell and gene therapy products, or other products approved by the Center for Biologics Evaluation and Research (CBER) in 2021

In 2021, the US FDA approved a total of 23 breakthrough therapies, including 15 NDA applications (9 for the first time) and 8 BLA applications (4 for the first time)
.

The first approved EVKEEZA, JEMPERLI, RYBREVANT and NEXVIAZYME, four biological therapies deserve deep attention

References:

References:

1.

1.

2.
New drug approvals in 2021

3.
New Drugs Approval Report 2020

3.
New Drugs Approval Report 2020