FDA record in 2021: approved potential blockbuster drugs vs. potential blockbuster drugs to be approved soon

Time is fast.
Looking back over the past nine months, the FDA has approved a number of potential blockbuster drugs, and several potential blockbuster drugs will receive FDA responses this year
.

According to Fierce Pharma's official website, four potential blockbuster drugs, Argenx's efgartigimod, Utimes's bimekizumab, Roche/Chuwai's abrocitinib, and Pfizer's abrocitinib, are expected to receive FDA approval in the next three months
.

1.
efgartigimod

Efgartigimod is a monoclonal antibody that targets the neonatal Fc receptor (FcRn)
.

In May 2020, the pivotal phase 3 clinical trial ADAPT of efgartigimod for the treatment of anti-acetylcholine receptor (AChR) antibody-positive systemic myasthenia gravis (gMG) patients reached the primary endpoint: compared with the placebo group, the efgartigimod treatment group has more A high proportion of patients were responders (67.
7% vs 29.
7%; p<0.
0001)
.

In 2021, Argenx submitted the BLA of efgartigimod to the FDA for the treatment of gMG, becoming the first anti-FcRn monoclonal antibody to submit BLA, and its target competitors Utimes's rozanolixizumab, Johnson & Johnson's nipocalimab, HanAll Biopharma/ and Platinum Pharmaceuticals HBM9161 and others are in phase 3 clinical trials
.

2.
bimekizumab

bimekizumab is a new humanized monoclonal IgG1 antibody targeting IL-17A and IL-17F
.

In September 2020, the FDA and EMA simultaneously accepted the regulatory application of bimekizumab for the treatment of adult patients with moderate to severe plaque psoriasis
.

It is worth mentioning that in the phase 3 study of the treatment of moderate to severe plaque psoriasis, bimekizumab is more effective than Johnson & Johnson IL-12/IL-23 inhibitors Stelara (ustekinumab, ustekinumab) and AbbVie Humira (adalimumab, adalimumab) and Novartis’ IL-17A inhibitor Cosentyx (secukinumab, secukinumab)
.

3.
faricimab

Faricimab is the first bispecific antibody specifically designed for the eye
.

Faricimab is the first injectable ophthalmic drug to achieve a 4-month dosing interval in the Phase 3 study of the treatment of DME and nAMD.
It is expected to become the first new type of treatment for nAMD in 15 years and the first new type of treatment for DME in the past 10 years.
Drugs pose a threat to VEGF/VEGFR inhibitors such as aflibercept, conbercept and ranibizumab.
The industry estimates that its sales in 2026 are expected to reach 1.
1 billion US dollars
.

4.
abrocitinib

abrocitinib is an oral small molecule JAK1 inhibitor.
It is currently combined with the subcutaneous injection preparation Dupixent (dupilumab, dupilumab) for the treatment of moderate to severe atopic dermatitis (AD) head-to-head stage 3 JADE DARE (B7451050) ) The study has achieved positive results: Compared with Dupixent, abrocitinib has statistical superiority in every efficacy index evaluated, and its safety is consistent with previous studies
.

As Pfizer’s JAK inhibitor Xeljanz has caused a series of safety incidents in patients, due to safety considerations, the marketing applications of many JAK inhibitors have been postponed or rejected
.

Potential blockbuster drugs approved by the FDA in 2021

In addition to the aforementioned blockbuster drugs that will be approved, according to incomplete statistics, the FDA has approved a number of potential blockbuster drugs as of 2021.
See the table below for details
.

Skytrofa is the world's only human growth hormone prodrug designed with the patented "Transient Conjugation" technology and is administered once a week
.

Aducanumab is a recombinant chimeric human IgG1 monoclonal antibody that targets β-amyloid protein jointly developed by Bojian and Eisai Pharmaceutical.
It was approved by the FDA in June this year for the treatment of early Alzheimer's disease
.
Evaluate Pharma predicts that its sales in 2026 are expected to reach 4.
9 billion US dollars
.

Lumakras is the world's first KRAS targeted drug approved by the FDA in May 2021 for the treatment of non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations.
The industry predicts that its sales in 2026 will be close to 2 billion U.
S.
dollars
.

Zynlonta is the first CD19-targeted antibody conjugate (ADC) approved globally.
It was approved by the FDA in April 2021 for the treatment of relapsed or refractory (r/r) patients who have received 2 or more systemic therapies.
Adult patients with B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), DLBCL originating from low-grade lymphoma and high-grade cell lymphoma
.
The industry predicts that its 2026 sales are expected to reach 1.
025 billion U.
S.
dollars
.

Breyanzi was originally developed by Juno and is a CD19-targeted CAR-T cell therapy
.
Compared with other CAR-T therapies that have been on the market, Breyanzi has the best safety data.
Its unique feature is that the ratio of CD8-positive and CD4-positive T cells in CAR-T therapy is controlled (1:1), so that it can be better Control the side effects of cell therapy
.
In February 2021, the drug was approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma in two or more systemic treatments, and became the fourth FDA-approved CAR-T cell therapy
.
The industry predicts that Breyanzi's global sales will reach 1.
38 billion U.
S.
dollars in 2024
.

Lupkynis is a calcineurin inhibitor that stabilizes the kidney cells that may be damaged in patients with advanced lupus nephritis by blocking IL-2 protein inflammation
.
In January 2021, the drug was approved by the FDA to treat adult patients with active lupus nephritis in combination with immunosuppressive therapy, becoming the second FDA-approved treatment for lupus nephritis after Benlysta
.
Compared with Benlysta administered subcutaneously or intravenously, Lupkynis is administered orally, and patient compliance is better.
The industry predicts that its global sales may reach US$1.
063 billion by 2026
.