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In 2022, the US FDA approved the in-depth inventory of new drugs

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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2022 is coming to an end, and as of December 16 this year, the US FDA's Center for Drug Evaluation and Research (CDER) has approved 32 innovative drugs
.
The FDA's Center for Biologics Evaluation and Research (CBER) has also approved at least 13 Biologics Licensing Applications (BLAs).

Although the number of new drugs approved by the FDA this year has decreased compared to previous years, the pace of innovation has not slowed down
.
Among the new drugs approved by the FDA this year, the proportion of new molecular therapies has reached a record high
.
The proportion of "first-in-class" therapies has also been the highest in the
past eight years.

Among the new drugs approved by the FDA this year, the proportion of new molecular therapies has reached a record high
.
The proportion of "first-in-class" therapies has also been the highest in the
past eight years.

The definition of new molecular therapies here includes bispecific antibodies/proteins, RNAi therapies, antisense oligonucleotide therapies (ASOs), gene therapies (including cell-based gene therapies), mRNA therapies or vaccines, oncolytic viruses, microbiome therapies, and antibody drug conjugates (ADCs).

These treatment modalities offer different modalities for targeting disease targets than traditional small molecule drugs, peptides, and antibodies, and may lead to superior or long-lasting efficacy
.

As of December 16, the FDA has approved 12 new molecular therapies, the highest number of new molecular therapies approved in nearly 10 years, indicating the trend
of vigorous development of new treatment models.
Among the 12 new molecular therapies, there are 5 cell and gene therapies involving genetic modification, 3 bispecific antibody/protein therapies, 1 RNAi therapy, 1 mRNA vaccine, 1 microbiome therapy and 1 antibody conjugate.

The number of 12 new molecular therapies and the proportion of new molecular therapies approved by the FDA reached the highest in nearly 10 years: 5 genetically modified cell and gene therapies, 3 bispecific antibody/protein therapies, 1 RNAi therapy, 1 mRNA vaccine, 1 microbiome therapy and 1 antibody conjugate.

▲Number of new molecular therapies approved by the FDA and their proportion of CDER and CBER approved products (Source: Public information, as of December 16, 2022, WuXi AppTec content team graphic)

This year, the FDA's Center for Drug Evaluation and Research approved at least 19 "first-in-class" therapies, accounting for 56 percent
of the total number of new drugs approved.
Although the total number of "first-in-class" new drugs approved this year is not high, its proportion still reaches the highest value
in nearly 10 years.
These new drugs have different mechanisms of action than existing therapies and have the potential to have important positive effects
on public health.

▲ From 2015 to 2022, among the new drugs approved by the FDA's CDER, the number and proportion of "first-in-class" (FIC) new drugs, click the picture to watch the larger picture (data source: public data collation, data before 2021 from the annual report released by CDER, FIC therapy statistics in 2022 include the "first-in-class" therapy mentioned in news reports by drug development companies, FDA or authoritative channels, Drugs that are not referred to as "first-in-class" in news reports are not included in the statistics)

The number of breakthrough therapies is also a measure
of innovation.
Of the 32 new drugs approved by CDER this year, a total of 11 new drugs have received breakthrough therapy designation
.
These therapies may demonstrate better clinical benefit
in treating specific serious diseases than existing therapies.

Eleven new drugs received breakthrough therapy designation
.
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)

Below we have selected 10 new drugs that have completed the "zero to one" breakthrough for a brief introduction (in no particular order).

Reports of the approval of these new drugs have attracted widespread attention
after the release of WuXi AppTec's WeChat platform.

Kimmtrak: The first TCR therapy

In January this year, the US FDA approved the first T cell receptor (TCR) therapy Kimmtrak (tebentafusp), a bispecific protein developed by Immunocore that targets gp100, which is fused by soluble TCR with high affinity and an effector domain that binds to CD3 receptors on the surface of T cells
.
This is not only the first FDA-approved TCR therapy, but also the first FDA-approved bispecific T cell adaptor protein
for the treatment of solid tumors.

First FDA-approved bispecific T cell adaptor protein
for the treatment of solid tumors.

Vabysmo: The first bispecific therapy for ophthalmic diseases

In January, the FDA approved Genentech's Vabysmo (faricimab) for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

As a bispecific antibody, Vabysmo simultaneously targets and blocks two key signaling pathways, angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

Relatlimab: The first approved LAG-3 antibody

In March, Bristol-Myers Squibb announced that the US FDA approved its "first-in-class" anti-LAG-3 antibody drug relatlimab for the use of Opdivo, an anti-PD-1 antibody, to treat patients
with unresectable or metastatic melanoma.
This is the first immunotherapy
approved by the US FDA in nearly 10 years to target a new immune checkpoint protein.

Mounjaro: The first new diabetes drug type in nearly 10 years

In May, Eli Lilly announced that the US FDA approved its glucose-dependent insulin stimulating peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist Mounjaro (tirzepatide) for use in combination with diet and exercise to improve glycemic control
in adults with type 2 diabetes.
This represents the first new diabetes drug type
in nearly 10 years.

Sotyktu: The first approved TYK2 allosteric inhibitor

In September this year, the US FDA approved Bristol-Myers Squibb's (BMS) orally selective TYK2 inhibitor Sotyktu (deucravacitinib, deuterium colexitinib tablets) for the treatment of adult patients
with moderate to severe psoriasis.
The press release noted that this is the first FDA-approved TYK2 inhibitor and the first innovation
in oral therapy for the treatment of moderate to severe psoriasis in nearly 10 years.
It also represents two breakthroughs in new drug development: it is the first approved new drug to intentionally use deuterated means in the drug design process; It is also the first allosteric inhibitor
approved to inhibit kinase activity by targeting the pseudokinase protein domain.

It is the first approved new drug to intentionally use deuterated means in the drug design process; It is also the first allosteric inhibitor
approved to inhibit kinase activity by targeting the pseudokinase protein domain.

Hemgenix: The first gene therapy to treat hemophilia B

In November, the U.
S.
FDA approved the joint development of Hemgenix (etranacogene) by CSL Behring and uniQure dezaparvovec), the first FDA-approved gene therapy
to treat adult patients with hemophilia B.
It uses an AAV5 vector that will express coagulation factor IX The transgenic Padua variant is delivered to the liver, and the newly synthesized clotting factor IX can promote blood clotting and reduce bleeding events
.

Rebyota: The first fecal microbiome therapy

In November this year, the U.
S.
FDA approved it by Ferring Rebyota, a microbiome therapy developed by Pharmaceuticals and Rebiotix, is designed to prevent the recurrence
of infection after antibiotic therapy in adults over the age of 18 with Clostridium difficile infection (CDI).
This is the first FDA-approved fecal microbiome therapy
.

Tzield: The first drug to delay the onset of type 1 diabetes

In November, the FDA approved Provention Bio's drug Tzield (teplizumab) is marketed to delay the course
of the disease in specific high-risk groups of type 1 diabetes.
Teplizumab, an anti-CD3 monoclonal antibody, promises to stop attacking insulin-producing cells by binding to specific immune cells
.

Relyvrio: A century of stubborn diseases ushered in innovative treatments

In September this year, the US FDA approved the marketing of Relyvrio (an oral fixed-dose formulation of sodium phenylbutyrate and diol taurate) developed by Amylyx for the treatment of amyotrophic lateral sclerosis (ALS).

Bringing the third FDA-approved therapy
to this 100% mortality rate for a century-old disease.
Relyvrio is a two-drug sodium phenylbutyrate (sodium phenylbutyrate) and a combination of taurursodiol
.
They improve the health of the mitochondria and endoplasmic reticulum within cells, thereby delaying the death
of nerve cells.
The company notes that this is the first time in a clinical trial that
improves patient function while prolonging a patient's life.

Skysona: The first FDA-approved gene therapy for the treatment of early cerebral adrenal leukodystrophy

In September, the US FDA accelerated its approval of the gene therapy Skysona (elivaldogene Autotemcel, also known as eli-cel), is marketed to delay the progression
of neurological dysfunction in boys aged 4-17 years with early active cerebral adrenal leukodystrophy (CALD).
Skysona uses lentiviral vectors to introduce a functional copy of the ABCD1 gene into the patient's own hematopoietic stem cells in vitro, and then transfuses it back into the patient, by expressing the ALD protein, preventing the progression of CALD and preserving nerve function
as much as possible.

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!

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