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At the beginning of the new year, the US FDA's Center for Drug Evaluation and Research (CDER) released the 2022 new drug approval report
.
During the year, CDER approved a total of 37 new drugs
.
Over the past 10 years, CDER has approved an average of 43 new drugs
per year.
per year.
In terms of innovation, among the new drugs approved by the FDA this year, a total of 20 are "first-in-class" therapies, accounting for 54.
1% (20/37) of the total number of new drugs approved throughout the year! Historically, the share of "first-in-class" new drugs is very close to last year's 54%, the highest value
in nearly a decade.
These new drugs have different mechanisms of action than existing therapies and have the potential to have important positive effects
on public health.
1% (20/37) of the total number of new drugs approved throughout the year! These new drugs have different mechanisms of action than existing therapies and have the potential to have important positive effects
on public health.
▲ Among the new drugs approved by the FDA CDER from 2015 to 2022, the number and proportion of new drugs of "first-in-class" (FIC), click the picture to watch a large picture (data source: public data collation, data from the annual report released by CDER)
▲ Among the new drugs approved by the FDA CDER from 2015 to 2022, the number and proportion of new drugs of "first-in-class" (FIC), click the picture to watch a large picture (data source: public data collation, data from the annual report released by CDER)New "first-in-class" drugs highlighted in the CDER report include:
New "first-in-class" drugs highlighted in the CDER report include:Camzyos (mavacamten) is an allosteric myosin allosteric inhibitor used to improve the treatment of selected obstructive hypertrophic cardiomyopathy (oHCM
) in adults.
This is the first FDA-approved allosteric reversible inhibitor
of myosin.
Mounjaro（tirzepatide）
Activating both hormone receptors at the same time provides better blood sugar control
.
It was approved by the FDA last May for use in combination with diet control and exercise to improve blood sugar control
in adults with type 2 diabetes.
Pluvicto（lutetium 177 Lu vipivotide
tetraxetan) is the first targeted radioligand therapy for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), which combines isotope therapy with targeted compounds
.
Sunlenca (lenacapavir) is a "first-in-class" capsid inhibitor
with a multi-stage mechanism of action.
It was approved in December last year for use in combination with other antiretrovirals to treat multidrug-resistant adult patients with human immunodeficiency virus (HIV) infection
.
Sunlenca is the first capsid inhibitor-based HIV treatment option, a "first-in-class" drug that offers a new, biannual treatment option
to HIV patients.
Tzield (teplizumab) is the first drug
to delay the onset of type 1 diabetes.
It is an anti-CD3 monoclonal antibody that promises to stop attacking insulin-producing cells by binding to specific immune cells
.
Voquezna Triple Pak (triple combination of vonoraxen, amoxicillin, clarithromycin) and Voquezna Dual
Pak (a double combination of vonoraxen and amoxicillin) was approved for marketing in May last year for the treatment of Helicobacter pylori in adults
Pylori) infection
.
Both combinations contain vonoraxen, a "first-in-class" potassium-competitive acid blocker that is the first innovative acid-suppressing therapy
derived from a new drug type approved in the United States in more than 30 years.
from a new drug type approved in more than 30 years.
FDA facilitates and accelerates new drug reviews in a number of ways
FDA facilitates and accelerates new drug reviews in a number of waysAmong the 37 new drugs approved in 2022, 12 received fast-track status, 13 received breakthrough therapy designation, 21 were eligible for priority review (excluding drugs submitted with priority review vouchers), and 6 drugs received accelerated approval
.
A total of 24 drugs used one or more eligibility determinations to expedite the review process
.
The number of breakthrough therapies is also a measure
of innovation.
These therapies may demonstrate better clinical benefit
in treating specific serious diseases than existing therapies.
▲New drugs approved by CDER in 2022 that have been certified as breakthrough therapies, click on the picture to see a larger picture (data source: public information, WuXi AppTec content team mapping)
▲New drugs approved by CDER in 2022 that have been certified as breakthrough therapies, click on the picture to see a larger picture (data source: public information, WuXi AppTec content team mapping)Multiple approvals lead to the first approved therapies for specific patient populations
Multiple approvals lead to the first approved therapies for specific patient populationsIn the report, CDER also highlights a number of noteworthy extended indication approvals
.
Several of these approvals resulted in the first FDA-approved therapies
for specific patient populations.
They include:
Dupixent (dupilumab) became the first FDA-approved therapy to treat eosinophilic esophagitis in 2022, and the first FDA-approved drug to treat prurigo nodosum in the same year
.
Enhertu（trastuzumab
deruxtecan) received accelerated approval in 2022, becoming the first therapy
to treat patients with a subtype of HER2-low breast cancer.
This is a new subset of HER2-negative breast cancer patients who express the HER2 protein on the surface of cancer cells but are not large enough to be classified as HER2-positive
.
Imcivree (setmelanotide) became the first FDA-approved therapy
to help people with Bardet-Biedl syndrome manage their weight in 2022.
Olumiant (baricitinib) became the first immunosuppressant approved for COVID-19 in 2022 and the first FDA-approved systemic therapy
for alopecia areata.
Opdivo (nivolumab) became the first CDER-approved neoadjuvant therapy
for lung cancer in 2022.
The topical JAK inhibitor Opzelura (ruxolitinib) is the first therapy approved by CDER to help restore skin pigment in patients with non-segmental vitiligo
.
Pedmark（sodium
thiosulfate) is the first approved therapy
to reduce the risk of hearing loss in pediatric patients undergoing cisplatin chemotherapy.
to reduce the risk of hearing loss in pediatric patients undergoing cisplatin chemotherapy.
Vidaza (azacitidine) received CDER approval in 2022 to treat newly
diagnosed patients with juvenile myelomonocytic leukemia older than one month.
This is the first approved treatment
for this type of leukemia.
diagnosed patients with juvenile myelomonocytic leukemia older than one month.
Vijoice (alpelisib) was approved in 2022 for the treatment of PIK3CA-associated hypergrowth disease lineage (PROS) (PROS), a rare overgrowth syndrome
that primarily affects children.
This is the first approved therapy
for this indication.
Xalkori (crizotinib) is approved for the treatment of patients with
unresectable, relapsed or refractory inflammatory ALK-positive myofibroblastoma (IMT).
This is the first approved drug
for the treatment of IMT.
unresectable, relapsed or refractory inflammatory ALK-positive myofibroblastoma (IMT).
The CDER report also reports on approvals for expanding drug use groups, as well as approvals for biosimilars, which can be described as "full of dry goods"
.
Click "Read Full/Read" at the end of the article
more" to download the full report
.
.
In 2023, we expect to see more innovative therapies being approved, bringing new treatment options
to patients around the world.
WuXi AppTec's content team will also continue to report the latest developments in new drugs around the world, so stay tuned!
Attached: List of new drugs approved by the FDA in 2022, click on the picture to see a larger picture
Attached: List of new drugs approved by the FDA in 2022, click on the picture to see a larger picture
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