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2022 FDA Approved Drug Analysis (Part I)

 Last Update: 2023-02-03
 Source: Internet
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In 2022, the FDA is still affected by the follow-up to Biogen's Alzheimer's drug Aduhelm, and is being extra cautious
when approaching innovative therapies.
Since 2017, the FDA has approved an average of 51 innovative therapies per year, but this year only 37 innovative drugs and 8 cell/gene therapies have been approved, a total of 45.

NO.
1 Quviviq

Indications: insomnia

R&D company: Idorsia

Date of approval: 7 January

Earlier this year, the FDA approved Quviviq for the treatment of insomnia, but because of its potential for abuse or dependence, the FDA recommended that it be listed as a controlled substance until approved by the U.
S.
Drug Enforcement Administration
.

Unlike traditional therapies, Quviviq is an orexin designed inhibitor as the latest dual orexin receptor antagonist that makes it easier for people to enter a natural sleep state
by blocking the lucid-promoting orexin.
In a pivotal phase III clinical trial, Quviviq was able to significantly improve patients' sleep conditions
.

Quviviq is not the first to eat crabs, as early as 2014 and 2019, the same type of drugs Belsomra (Merck) and Dayvigo (Eisai) have been on the market, both of which were warned by the FDA for safety risks because of the next day residual effect, Quviviq still has a long
way to go.

NO.
2 Cibinqo

Indications: atopic dermatitis

R&D company: Pfizer

Date of ratification: 14 January

Cibinqo is an oral JAK1 inhibitor used primarily to treat adult patients
with refractory moderate to severe atopic dermatitis.
Previously, the drug has demonstrated safety and efficacy in large-scale clinical trials and was approved by EMA in
December 2021.

In these trials, Cibinqo demonstrated a consistent safety profile, significantly improving lesion clearance, disease extent and severity compared with placebo, and rapid improvement in pruritus
over a two-week period of treatment.
The active ingredient of the drug is abrocitinib, which selectively inhibits JAK1, which is thought to regulate a variety of cytokines involved in the pathophysiological process of atopic dermatitis, including IL-4, IL-13, IL-31 and others
.

NO.
3 Kimmtrak

Indications: uveal melanoma

R&D company: Immunocore

Date of approval: 25 January

Immunocore's world's first T-cell receptor (TCR) therapy, Kimmtrak, was approved by the FDA for the treatment of adult patients
with HLA-A*02:01 positive unresectable or metastatic uveal melanoma.

Uveal melanoma is a highly aggressive disease with low survival and poor prognosis
.
In the phase III clinical trial of the drug, the Kimmtrak treatment group showed statistically significant and clinically significant overall survival benefits, compared with the investigator's chosen regimen, reduced the risk of death by 49%, and the median overall survival was nearly 22 months
.

NO.
4 Vabysmo

Indications: macular degeneration, diabetic macular edema

R&D company: Roche

Date of ratification: 28 January

Vabysmo, a bispecific antibody studied by Roche's Genentech, is used to treat neovascular or "wet" age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The launch of the drug marks a significant advancement in nAMD and DME treatment regimens, which can provide patients with a more diversified dosing regimen
.
Compared with the current standard treatment regimen, Vabysmo can reduce the frequency of injections, reduce the burden of treatment, and the active pharmaceutical ingredient faricimab can target angiopoietin-2 and vascular endothelial growth factor A, stabilize blood vessels, reduce inflammatory response and leakage, and better improve vision
.

NO.
5 Spikevax

Indications: New coronavirus prevention

R&D company: Moderna

Date of approval: 1 January

On December 18, 2020, the vaccine received FDA emergency use authorization for the first time, and was officially approved by the FDA on January 31, 2022, to prevent infection with the novel coronavirus
in people over the age of 18.

As a cash cow for Moderna, Spikevax is 93.
2% effective in preventing symptoms in new crown patients, including 93.
4% in people aged 18-65 and 91.
5%
in people over 65 years old.
The vaccine also became the second new coronavirus vaccine approved in the United States after the Pfizer new crown vaccine
.

NO.
6 Enjaymo

Indications: cold agglutinin disease

R&D company: Sanofi

Date of approval: 2 January

Cold agglutinin disease is a rare autoimmune disease in which the body's red blood cells are destroyed in cold conditions and cause anemia
.
Enjaymo is currently the only approved treatment regimen that reduces the need
for red blood cell transfusion due to hemolysis and destruction of red blood cells in adults with cold agglutinin disease.

Enjaymo is an IgG4 monoclonal antibody designed to selectively target and inhibit C1
in the classical complement pathway.
By inhibiting C1, the drug can inhibit the activation of the complement cascade in the immune system and prevent hemolysis in patients with cold agglutinin disease, protecting healthy red blood cells from destruction
.

NO.
7 Pyrukynd

Indications: hemolytic anemia in adults

R&D company: Agios

Date of approval: 2 January

Pyruvate kinase (PK) deficiency is a rare genetic disorder manifested by chronic hemolytic anemia
.
Pyrukynd is the first FDA-approved treatment
for the disease.

The FDA's decision was based on the results of two key studies, in the ACTIVATE trial, in which Pyrukynd was able to show a significant increase in hemoglobin in PK deficiency patients with irregular blood transfusions; In the ACTIVATE-T trial, the drug met its primary endpoint and showed a statistically significant and clinically significant reduction
in the transfusion burden in patients with regular transfusions.

NO.
8 Carvykti‍

Indications: Multiple myeloma

R&D companies: Johnson & Johnson, Legend Biotech

Date of approval: 2 January

Legend's collaboration with Johnson & Johnson and Johnson & Johnson's chimeric antigen receptor T cell (CAR-T) therapy, Carvykti, was approved by the FDA this year for the treatment of patients
with relapsed or refractory multiple myeloma who have previously received four or more treatments.

As the first cell therapy independently developed in China and approved for marketing overseas, the overall response rate (ORR) reached 98% in the pivotal CARTITUDE-1 study, 78% of patients achieved a strict complete response (sCR), and the median duration of response (DOR) was 21.
8 months in the median follow-up of 18 months
.

NO.
9 Vonjo

Indications: myelofibrosis

R&D company: CTI BioPharma

Date of approval: 2 January

The FDA approved Vonjo for the treatment of adult patients
with moderate or high-risk primary or secondary myelofibrosis and platelet levels below 50,000/microL.

Myelofibrosis is a rare spinal cord disorder that disrupts the formation of blood cells, leading to severe anemia, a condition that usually results in an enlarged
spleen.
In Vonjo's pivotal clinical trial, 63 patients with moderate to high-risk primary or secondary myelofibrosis and low platelets were divided into Vonjo and standard of care
.
The results showed that 29% of patients in the Vonjo group experienced a reduction in spleen volume of more than 35%, compared with only 3% of patients in the standard treatment group
.

NO.
10 Ztalmy

Indications: epilepsy

R&D company: Marinus Pharmaceuticals

Date of approval: 3 January

Ztalmy is a neuroactive steroid that functions as a GABAA receptor forward allosteric modulator for the treatment of epilepsy
associated with cyclin-dependent kinase-like 5 deficiency (CDKL5) deficiency.

Based on data from the Phase III Marigold trial, out of 101 patients, patients in the Ztalmy group had a 30.
7% reduction in the median frequency of major motor episodes over 28 days, compared with a 6.
9% reduction in the placebo group, meeting the primary endpoint
of the trial.
In the Marigold open-label extension study, patients treated with Ztalmy for at least 12 months had a 49.
6%
reduction in the median frequency of major motor seizures.

NO.
11 Opdualag

Indications: Melanoma

R&D company: Bristol Myers Squibb

Date of approval: 3 January

Opdualag is First-In-Class's dual immunization combined fixed-dose combination reagent containing nivolumab and relatlimab for the treatment of adults and children 12 years of age and older with unresectable or metastatic melanoma
.

According to the RELATIVITY-047 study, Opdualag more than doubled median progression-free survival (PFS) compared to standard therapy nivolumab monotherapy (10.
1 months VS 4.
6 months), the safety profile of the combination group was also broadly consistent
with nivolumab alone.

NO.
12 Pluvicto

Indications: Prostate cancer

R&D company: Novartis

Date of approval: 3 January

Pluvicto is approved for the treatment of adults with advanced prostate-specific membrane antigen-positive, metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor pathway inhibitor therapy and
taxane-based chemotherapy.

The drug is mainly used to target prostate-specific membrane antigen, which is highly specific for benign and malignant prostate epithelial cells, is present in approximately 80% of mCRPC patients, and is a potential target for the diagnosis and treatment of
the disease.
In the Phase III VISION trial, subjects received Pluvicto+ Best Standard of Care (BSoC) or only Best Standard Care
in a 2:1 ratio.
The results showed that there were significant improvements in overall survival (OS) and radiographic progression-free survival (rPFS) in the combination group, with a median OS of 15.
3 months and 11.
3 months in the control group, and 8.
7 months in the combination rPFS and 3.
4 months
in the control group.

NO.
13 Vivjoa

Indications: recurrent vulvovaginal candidiasis

R&D company: Mycovia Pharmaceuticals

Date of approval: 4 January

Vivjoa is a novel oral inhibitor of fungal CYP51 used to reduce the incidence
of recurrent vulvovaginal candidiasis (RVVC) in women with no fertility potential.

Data from three phase III clinical trials of Vivjoa (two global studies and one US center study) evaluated the efficacy and safety
of the drug in women 12 years of age and older who have had at least three episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.
According to the results, 89.
7% of patients treated with Vivjoa cleared the primary infection and did not relapse during the 50-week maintenance period, compared with 57.
1% of patients treated with fluconazole and placebo

NO.
14 Camzyos

Indications: Hypertrophic cardiomyopathy

R&D companies: Bristol Myers Squibb, MyoKardia

Date of approval: 4 January

Camzyos, developed by LianBio in collaboration with BMS, is used to treat adult patients
with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) with a New York Heart Association cardiac function class II-III.

Camzyos is an allosteric reversible inhibitor of myosin-selective that regulates the number of myosin heads entering the "actin-bindable" state, thereby reducing the probability
of kinetic generation and residual crossbridge formation.
The formation of excess myosin-actin transverse bridges and dysregulation of the ultrarelaxed state are mechanistic features
of HCM.
Camzyos can transform the overall myosin population into an energy-efficient, recruitable ultra-relaxed state
.

NO.
15 Voquezna‍

Indications: Helicobacter pylori infection

R&D company: Phathom Pharmaceuticals

Date of approval: 5 January

Voquezna is available in triple packs (vonoprazan/amoxicillin/clarithromycin) and duo (vonoprazan/amoxicillin), a novel first-of-its-kind oral small molecule potassium-competitive acid blocker (PCAB) that has been shown to have rapid and long-lasting antisecretory effects
.
Acid inhibitor therapy has long been established as the mainstay of the treatment of Helicobacter pylori, and more effective acid inhibitors will help increase the eradication rate
of current treatment regimens.

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