Top 10 Most Anticipated New Drugs in 2021

On February 22, FiercePharma selected the 10 most anticipated new drugs on the market in 2021 based on the estimated global new drug sales data for 2026 by Evaluate Pharma. Among them, Biogen's Aducanumab, an Alzheimer's drug candidate leads the list. Other diseases such as psoriasis, KRAS G12C mutations, Duchenne muscular dystrophy, and hypercholesterolemia will also usher in breaking through therapy.

TOP1
Name: Aducanumab
Company: Biogen
Direction: Alzheimer's Disease (AD)
Estimated sales in 2026: $4.8 billion

In January 2021, the US FDA postponed the priority review period for Biogen's Alzheimer's disease drug Aducanumab to June 7. Although the FDA panel voted overwhelmingly to deny the drug by 8:1, the postponement of this review indicates that the FDA is still considering its approval. Affected by this, Biogen's stock price rose sharply.

Alzheimer's disease (AD) (https://www.creative-biolabs.com/vaccine/vaccines-against-alzheimer-dise...) is a progressive neurodegenerative disease with an insidious onset. There are currently about 50 million AD patients across the world, which is expected to increase to 152 million by 2050. Unfortunately, no drug that can effectively treat this disease has yet been developed.

Aducanumab is a human monoclonal antibody (mAb) that binds to the β-amyloid protein, and it is also the first biological agent for AD-related clinical symptom reduction and pathological mechanisms submitted to regulatory agencies. If the drug is successfully approved, it may become the first therapy to meaningfully change the course of AD.

It is estimated that sales of the drug will reach 271 million USD in 2021, 765 million USD by 2022, and by 2026, the sales will reach 4.94 billion USD.

TOP2
Name: NVX-CoV2373
Company: Novavax
Direction: COVID-19 vaccine
Estimated sales in 2026: $2.73 billion

On January 28, Novavax announced the phase 3 clinical trial results of its COVID-19 recombinant protein vaccine NVX-CoV2373 in the UK, which showed up to 89% protection and has varying degrees of protection against variant strains discovered in the UK and South Africa.

According to Stanley Erck's speech at the JPM conference earlier year, Novavax will provide 110 million doses of vaccine to the US government in the second quarter of 2021.

It is estimated that the sales of NVX-CoV2373 in 2021 are expected to reach 2.37 billion USD, and the total sales will remain at about 2.73 billion USD by 2026.

TOP3
Name: Efgartigimod
Company: Argenx
Direction: IgG-mediated autoimmune diseases
Estimated sales in 2026: $2.5 billion

In May 2020, Argenx announced that its FcRn-targeting drug Efgartigimod had reached the primary endpoint in phase 3 clinical trial for patients with systemic myasthenia gravis (gMG), and 67.7% of patients had improved symptoms after receiving treatment.

FcRn is a protective receptor for immunoglobulin G (IgG). Blocking FcRn can reduce pathogenic IgG antibodies associated with several autoimmune diseases. The target has attracted pharmaceuticals such as Alexion, Immunovant, and UCB, but Argenx is currently the pioneer.

TOP4
Name: Bardoxolone methyl
Company: Reata Pharmaceuticals
Direction: Chronic Kidney Disease
Estimated sales in 2026: $2.5 billion

Alport syndrome is the most common type of hereditary nephritis. Most patients develop hematuria before the age of 10, and hematuria (distorted red blood cell hematuria) is the prominent and first manifestation. Gene mutation is the cause and there is no effective treatment.

Bardoxolone methyl is an oral, once-daily Nrf2 activator, which can induce the restoration of mitochondrial function, reduce oxidative stress, and inhibit the molecular pathways of pro-inflammatory signals to promote the resolution of inflammation. Public information shows that Reata plans to submit a marketing application for the product to the FDA in the first quarter of 2021, and meanwhile applying for approval in Europe.

TOP5
Name: Deucravacitinib
Company: Bristol-Myers Squibb
Direction: Psoriasis and other inflammatory diseases
Estimated sales in 2026: $2.21 billion

At the beginning of February 2021, BMS announced that its new oral TYK2 inhibitor Deucravacitinib was far more effective than Otezla in phase 3 clinical trial for patients with moderate to severe plaque psoriasis. Compared with placebo, patients treated with Deucravacitinib for 16 weeks had a 75% reduction in psoriasis area and severity.

TYK2 is a member of the JAK family and plays an important role in mediating the signal transduction of pro-inflammatory cytokines such as IL-12, IL-23, and type I interferon. Deucravacitinib works by blocking TYK2.

TOP6
Name: Inclisiran
Company: Novartis
Direction: Hypercholesterolemia
Estimated sales in 2026: US$2.01 billion

In January 2021, Novartis spent US$9.4 billion to acquire The Medicines Company and obtained its first siRNA cholesterol-lowering drug Inclisiran that was originally planned to be approved by the end of 2020, but it was shelved due to the outbreak of COVID-19.

Inclisiran is the first cholesterol-lowering therapy in the small interfering RNA category, targeting the proprotein convertase subtilisin 9 (PCSK9), a key mechanism that regulates LDL-C. In clinical trials, the product has comparable efficacy to two existing mAb drugs (Repatha of Amgen and Praluent of Sanofi/Regeneron) that target the PCSK9 protein. Novartis expects that Inclisiran may be approved by the FDA before the end of 2021.

TOP7
Name: SRP-9001
Company: Sarepta Therapeutics
Direction: Duchenne Muscular Dystrophy
Estimated sales in 2026: $1.88 billion

In January 2021, Sarepta Therapeutics announced the Phase 2 clinical trial data of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), which showed that the drug was not significantly better than placebo. Nevertheless, the company still has full confidence in this product. Previous data show that compared with Pfizer's PF-06939926, SRP-9001 has higher security.

TOP8
Name: Adagrasib
Company: Mirati Therapeutics
Direction: KRAS G12C mutant cancer
Estimated sales in 2026: $1.74 billion

In October 2020, Mirati Therapeutics announced that its KRAS drug MRTX849 took effect in 45% of non-small cell lung cancer (NSCLC) patients, far exceeding the data of 35% of Amgen's similar drug Sotorasib.

TOP9
Name: Bempegaldesleukin
Company: Nektar Therapeutics
Direction: Melanoma, renal cell carcinoma, and other cancers
Estimated sales in 2026: $1.72 billion

Bempegaldesleukin is a CD122-biased IL-2 pathway agonist. Nektar Therapeutics is currently combining it with Bristol-Myers Squibb’s Opdivo for four phase 3 clinical trials for metastatic cancers, such as metastatic melanoma, kidney cancer, and muscle invasive bladder cancer.

In November 2020, the combined therapy of bempeg-Opdivo showed 90% effectiveness in 20 patients with metastatic melanoma.

TOP10
Name: Bimekizumab
Company: UCB
Direction: Psoriasis
Estimated sales in 2026: $1.63 billion

In June 2020, UCB announced that its Bimekizumab has reduced the symptom area and severity of 85% of patients by more than 90% in phase 3 clinical trial for the treatment of psoriasis, surpassing the data of 50% of JNJ's similar drug Stelara. Currently, Phase 3 clinical trials for other diseases are in progress, including the treatment of psoriatic arthritis, ankylosing spondylitis, non-radiation axial spondylitis, and hidradenitis suppurativa.