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In 2021, the FDA approved 50 new drugs (only those approved by CDER are counted), which new drugs with "blockbuster" potential will be launched in 2022?
FiercePharma has released a list of the top ten most anticipated new drugs to market in 2022, most of which are still awaiting FDA approval
.
These drugs are forecast to have combined sales of $26.
9 billion by 2026, spanning areas such as Alzheimer's disease (AD), diabetes, psoriasis and lung cancer
It is worth mentioning that cilta-cel on the list has been approved by the FDA a few days ago, becoming the second CAR-T therapy targeting BCMA in the world
.
However, bardoxolone, which is also on the list, has been rejected by the FDA for chronic kidney disease caused by Alport syndrome, and more safety and efficacy data are needed
donanemab [company] Eli Lilly [indication] Alzheimer's disease [2026 sales forecast] $6 billion
In June last year, Biogen’s Aduhelm (aducanumab) targeting beta amyloid received accelerated approval from the FDA, and Evaluate had predicted that the drug’s peak sales in 2026 would be about $4.
8 billion
tirzepatide [Company] Eli Lilly [Indication] Diabetes [Sales forecast in 2026] $4.
9 billion
Eli Lilly's diabetes drug tirzepatide is in second place, with sales expected to reach $4.
9 billion in 2026
gantenerumab [Company] Roche [Indication] Alzheimer's Disease [Sales forecast in 2026] $2.
5 billion
Gantenerumab, like donanemab, is an anti-beta amyloid monoclonal antibody, but its 2026 sales forecast is less than half of the latter
.
For Roche, gantenerumab sales are also a huge amount of revenue if they can meet expectations, and more importantly, it will help the company further strengthen its position in the central nervous system disease market outside the traditionally strong oncology field
.
However, for AD drugs, while they have huge sales potential, they also come with huge risks
.
In fact, the research and development of gantenerumab also has twists and turns
.
In 2014, Roche put the drug on hold after a phase III study failed, and revived the drug in 2018 after considering that higher doses might stimulate efficacy
.
Therefore, it remains to be seen whether gantenerumab can obtain the clinical data needed to support approval
.
4 billion
Can deucravicitinib make up for the loss of BMS having to drop Otezla (Aprestel) due to its acquisition of Celgene? Maybe this year we can find out
.
In 2019, when the $74 billion super merger of Celgene faced antitrust hurdles, BMS chose to keep deucravicitinib, which is still in the research and development stage, and sold the well-growing "blockbuster" Otezla to Ann for $13.
4 billion.
enter
.
Data from the Phase 3 trial brought good news: in the POETYKPSO-1 and POETYKPSO-2 trials, deucravacitinib helped more patients with moderate-to-severe plaque psoriasis achieve skin clearance than Otezla
.
BMS is also pursuing expansion opportunities in deucravicitinib, a treatment for psoriatic arthritis and inflammatory bowel disease, which the company believes could peak at more than $4 billion, while Evaluate forecasts sales of $2.
4 billion in 2026
.
The target of deucravicitinib, TYK2, is a member of the JAK family, and there is uncertainty as to whether it can be used as a first-line treatment
.
Because the FDA issued a safety warning for oral JAK inhibitors about an increased risk of cancer and heart-related events, and limited their use to after patients have tried existing drugs
.
AstraZeneca and Amgen's asthma drug Tezspire (tezepelumab-ekko) received early FDA approval in December 2021 and was launched on the market in mid-January
.
As an add-on maintenance therapy, Tezspire has shown efficacy in a wide range of severe asthma patients and will have the opportunity to challenge the dominance of Regeneron and Sanofi's "blockbuster" Dupixent
.
Dupixent's sales cross the $5 billion mark in 2021
.
In 2018, the drug was approved by the FDA as maintenance therapy for moderate-to-severe eosinophilic, oral steroid-dependent asthma in patients whose disease is not controlled by current asthma medications
.
Dupixent is also approved for the treatment of moderate to severe atopic dermatitis, as well as the maintenance treatment of chronic sinusitis with nasal polyps
.
AstraZeneca and Amgen are also testing Tezspire in other indications, including chronic sinusitis with nasal polyps that could challenge Dupixent
.
8 billion
While Alnylam already has a drug targeting amyloid-transthyretin (ATTR) amyloidosis on the market, vutrisiran could give it an edge over Pfizer
.
The drug is a follow-up to Onpattro (patisiran), which is injected every 3 weeks, while vutrisiran is administered subcutaneously every 3 months, which is more convenient
.
Evaluate predicts that vutrisiran sales could reach $1.
8 billion in 2026, and the FDA is expected to make an approval decision on April 14 for the drug's ATTR polyneuropathy (ATTR-PN) indication
.
The market for ATTR cardiomyopathy (ATTR-CM) is even larger, with Pfizer's ATTR-CM drug Vyndaqel/Vyndamax (clofenac meglumine) surging 170% to $1.
288 billion in 2021
.
Trials of Onpattro and vutrisiran for this indication are ongoing
.
7 billion
For BMS, when its U.
S.
patent on Eliquis (apixaban), an anticoagulant developed in partnership with Pfizer, expires, mavacamten has the potential to become a new mainstay in the company's cardiovascular space
.
The drug is the core product of BMS' $13.
1 billion acquisition of MyoKardia in 2020, and it may "bloom and bear fruit" this year
.
BMS predicts that mavacamten's non-risk-adjusted revenue could exceed $4 billion in 2029, and Vantage expects the drug's sales to reach $1.
7 billion in 2026
.
The mavacamten was supposed to receive an FDA approval decision for its symptomatic obstructive hypertrophic cardiomyopathy (HCM) indication in January, but the FDA pushed the deadline by three months in November last year because it needed more time.
Develop a safety monitoring plan (risk assessment and mitigation strategy)
.
There is also no shortage of competition in the HCM therapeutic space
.
Last year, Cytokinetics announced positive Phase II data for its new HCM drug, Aficamten (CK-274)
.
The drug has been granted breakthrough therapy designation by the FDA, and a Phase III clinical trial called SEQUOIA-HCM is underway
.
7 billion
Although the approval deadline was delayed from the end of last year to February this year, cilta-cel was finally approved by the FDA as scheduled
.
The drug is a BCMA-targeting CAR-T therapy for the treatment of adults with relapsed and/or refractory multiple myeloma (R/RMM), designed and developed by Nanjing Legend Biotechnology, a subsidiary of GenScript
.
In December 2017, Johnson & Johnson's Janssen Biotechnology entered into an exclusive global license and collaboration agreement with Nanjing Legend to develop and commercialize cilta-cel
.
As a result, Cilta-cel has become the first successful example of domestic self-developed CAR-T products going overseas.
Evaluate predicts that the sales of this drug will reach 1.
7 billion US dollars in 2026
.
However, it also has many competitors: GSK's BCMA-targeted antibody-drug conjugate Blenrep (belantamabmafodotin-blmf) for certain types of relapsed/refractory multiple myeloma patients was approved in 2020, BMS and Bluebird Bio The CAR-T therapy Abecma (idecabtagenevicleucel, ide-cel), the most direct competitor of cilta-cel, was approved in March last year
.
In addition, Johnson & Johnson's own Darzalex (daratumumab), BMS' Revlimid (lenalidomide), and Takeda's proteasome inhibitor Velcade (bortezomib) are all blockbuster products in multiple myeloma
.
There are also Takeda's follow-up drugs Ninlaro (ixazomib) and Amgen's Kyprolis (carfilzomib) in this field
.
7 billion
In the KRAS inhibitor race to market, adagrasib lost out to Amgen's Lumakras (sotorasib), which won FDA approval last May for the treatment of non-small cell lung cancer (NSCLC) with a specific KRASG12C gene mutation
.
If adagrasib is approved for listing, although it is about a year later than Lumakras, it is more optimistic in the sales forecast for the fifth year after listing
.
Sales of Lumkras are forecast to reach $1.
3 billion in 2025, while adagrasib sales are forecast to reach $1.
7 billion in 2026
.
