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2022 has passed, and in the past year, innovative drugs have been launched in a blowout around the world
.
The US FDA alone has approved dozens of innovative drugs and therapies
.
Although the FDA's approval standards in 2022 became stricter compared with the data in 2021, and the number of new drugs approved under the background of FDA's anti-involution decreased somewhat, a number of innovative drugs were still approved, and according to incomplete statistics, the proportion of "First-in-Class" therapies in 2022 was also high compared with the data of the past many years
.
In addition to targeted drugs and immunosuppressants in the general sense, cell therapies such as CAR-T have also emerged, and a number of cell therapy products have been approved for marketing
in the United States.
Among them, the domestic CAR-T pioneer legendary biology is also among them, becoming one of the few domestic innovative drugs/therapies
that have successfully landed in the US market in 2022.
According to the incomplete statistical results of the new media center of "Medical Economics News", there are 37 innovative drugs approved by the US FDA in 2022, of which approved small molecule drugs still account for the majority of breakthrough/innovative drugs or therapies, about 19 small molecule drugs, accounting for more than 50%, followed by monoclonal antibody drugs, accounting for nearly 16%.
September is the month
of the explosion of the speed of FDA approval of new drugs in 2022.
In the same month, the FDA approved 9 drugs, including psoriasis, wrinkle removal, kidney function, ALS, cholangiocarcinoma and other drugs, accounting for about 24.
3%
of the total number of new drugs approved throughout the year.
It is worth mentioning that in addition to the above approved drugs, 4 gene therapies will be approved for marketing
in 2022.
Among them, 3 gene therapy drugs broke the record of the world's most expensive drugs three times in 2022, causing heated discussions
.
According to incomplete statistics, there are about 19 "First-in-Class" drugs among the dozens of innovative drugs/therapies approved by the US FDA's Center for Drug Evaluation and Research (CDER) in 2022, which is far less than the 27 FIC records in 2021, but the overall performance is also at the median level
in the past 8 years.
The approval of new drugs is only a small part of the many R&D hotspots, and there are still many new drug research and development, and innovative technologies are still on the way
.
We look forward to 2023 and see more innovative therapies being approved, meeting unmet clinical needs and bringing new treatment options
to patients around the world.
Now, let's take a look at some of the innovative products that are attracting attention!
First regulatory approval for TCR therapy
On January 25, the FDA approved Kimmtrak (tebentafusp-tebn),
the first treatment developed by Immunocore for the treatment of unresectable or metastatic uveal melanoma.
It is reported that this is also the first T cell receptor (TCR) therapy to receive regulatory approval, and the first bispecific T cell linker
approved by the FDA for the treatment of solid tumors.
Roche biantibodies
On January 28, the FDA approved Roche's anti-VEGF-A/Ang2 bispecific antibody Vabsmo (Faricimab)
for the treatment of wet age-related macular degeneration and diabetic macular edema.
Sanofi C1s complement protein
On February 4, the FDA approved Sanofi's monoclonal antibody Enjaymo (sutimlimab) for the C1s protein in the classical complement pathway, the first FDA-approved therapy for patients with cold agglutinin disease, which inhibits hemolysis caused by complement protein activation
.
Agios Pyrukynd
On February 17, the FDA approved Agios' Pyrukynd (mitapivat), the first modified therapy
for the treatment of hemolytic anemia caused by pyruvate kinase deficiency.
Multiple myeloma Vonjo
On February 28, CTI BioPharma Corp.
announced that the FDA approved VONJO (pacritinib) for the treatment of adult or secondary (after polycythemia vera or essential thrombocytosis) myelofibrosis
with moderate or high-risk primary.
Marinus: Ztalmy
On March 18, the FDA approved Ztalmy (ganaxolone, ganetholone),
the first drug to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency (CDD)-associated seizures.
The first combination therapy with LAG-3 monoclonal antibody
On March 18, BMS announced the approval of the marketing application for the fixed-dose combination combination of Opdualag (relatlimab+nivolumab, LAG-3+PD-1) for the treatment of unresectable or metastatic melanoma
in adults and adolescents over 12 years of age (weighing ≥ 40 kg).
It is reported that relatlimab is a globally approved class 3 immune checkpoint inhibitor
after CTLA-4 and PD-1/PD-L1.
BMS is also the first company
to market 3 different immune checkpoint inhibitors at the same time.
Novartis prostate cancer drug Pluvicto
On March 24, Novartis announced that the US Food and Drug Administration (FDA) has approved the marketing of the company's targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and androgen receptor signaling pathway inhibitors
.
The first RVVC drug
On April 26, the FDA approved Mycovia's new oral antifungal drug, Vivjoa (oteseconazole), to reduce the chance
of recurrence of recurrent vulvovaginal candidiasis (RVVC) in women with no reproductive potential.
This is the first FDA-approved drug
to treat RVVC.
Hengrui Pharmaceutical has introduced the drug and submitted a new drug application in China in January this year
BMS is another FIC drug
On April 28, Bristol-Myers Squibb (BMS) mavacamten was approved by the FDA for the treatment of adult patients with obstructive hypertrophic cardiomyopathy (oHCM) rated class II-III according to the New York Heart Association's functional scale (NYHA) to improve exercise capacity and symptoms
.
The product was certified
as a breakthrough therapy by CDE in February this year.
The first new diabetes-type drug in nearly a decade
On May 13, Eli Lilly announced that the US FDA approved the marketing of the company's glucose-dependent insulin stimulating peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist Mounjaro (tirzepatide).
It is reported that this drug only needs once a week and supplemented by diet control and exercise to improve blood sugar control in adult patients with type 2 diabetes, greatly improving the convenience of medication and long-term glycemic control
.
Eli Lilly said that Mounjaro represents the first new diabetes drug type
in nearly 10 years.
China's new drug breaks the 25-year deadlock in psoriasis treatment
On May 23, Dermavant Sciences announced that the FDA had approved VTAMA (tapinarof, 1%, Chinese: benvimod) cream for the topical treatment
of plaque psoriasis in adults.
It is reported that this product is the first and only steroid-free topical drug of its kind approved by the FDA, and it is also the first external new molecular solid drug
approved for the treatment of psoriasis in the United States in 25 years.
This is also a global innovative drug
with independent intellectual property rights (first-in-class) developed by local enterprise Tianji Pharmaceutical.
RNAi therapy for rare diseases
On June 13, the US FDA approved the drug Amvuttra (vutrisiran)
for the treatment of adult patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).
It is reported that the drug development is Alnylam
, an industry-leading RNAi therapy company.
It is worth mentioning that this drug is the first and currently the only treatment
that has been shown to reverse neuropathy damage with a 3-month subcutaneous injection.
The first first-line dual immune combination therapy for liver cancer
On October 21, the FDA approved AstraZeneca's CTLA-4 inhibitor Imjudo (tremelimumab) in combination with the PD-L1 inhibitor Imfinzi (durvalumab, Chinese: Infinefan) for the first-line treatment of patients
with unresectable hepatocellular carcinoma.
It is reported that this is also the first immunotherapy
successfully approved for the first-line treatment of liver cancer.
There is also a cure for type 1 diabetes
On November 18, the FDA announced the approval of Provention Bio's CD3 monoclonal antibody teplizumab for the use of patients with stage 3 diabetes mellitus in adults and stage 2 type 1 diabetes in children 8 years of age and older
.
It is reported that this is the only drug
that can delay the onset of type 1 diabetes so far.
"Fecal therapy" was approved and microbial drugs were launched
On November 30, the FDA approved Rebyota, a microbiome-based live biotherapy developed by Rebiotix, the first fecal microbiota product approved by the FDA to prevent recurrence of infection in adults over the age of 18 with Clostridium difficile infection (CDI
).
Some industry insiders said that this is the most embarrassing drug for patients: the drug needs to be made from feces donated by qualified personnel and then administered
rectally.
Gilead's long-acting HIV therapy approved
On December 22, Gilead announced that the FDA had approved Sunleca (Lenacapaivr) for marketing
.
It is reported that this drug is combined with other antiretrovirals to treat HIV-1 infection
in adults with multi-drug resistance and multiple treatment experience.
It is also the only HIV treatment drug approved for marketing in the world that only needs to be administered twice a year
.
It greatly improves the convenience of
medication for HIV patients.
Multiple sclerosis treatment drug ublituximab
On December 28, the FDA approved TG Therapeutics' adult multiple sclerosis treatment Briumvi (ublituximab), which is a CD20-directed antibody
.
It is known that this drug can be used to treat certain relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
in adults.
Currently, more than 2.
3 million people worldwide have been diagnosed with multiple sclerosis
.
