Top 10 most anticipated new drugs in 2022, Eli Lilly, Roche, BMS...
Source: Yaozhi Network/Clover
After the FDA approved 55 new drugs in 2021, more new drugs approved in 2022 will go all out to provide new therapies to patients.
On Feb. 7, the FiercePharma website ranked the most anticipated new drugs to market in 2022. According to EvaluateVantage's Life Sciences Data Report, the total revenue of the top 10 most anticipated drugs will reach $26.9 billion by the middle of this century. Among them, Eli Lilly's two drugs will be the most promising, with potential revenue from its new drugs for Alzheimer's and diabetes approaching $11 billion, accounting for nearly half of the revenue of the top ten new drugs.
In addition, like Eli Lilly, Bristol-Myers Squibb has two drugs in the top 10 most anticipated listings in 2022, with mavacamten, which is expected to be used to treat cardiomyopathy, and deubravacitinib, which treats psoriasis and autoimmune diseases, which is expected to peak sales of $4 billion.
However, although the top 10 drugs are worth looking forward to, it is not easy to get approved for marketing. For example, Cita-cel, developed by Johnson & Johnson and Legendary Biologics, was extended by the FDA for manufacturing and technical issues; Reata Pharmaceuticals' Bardoxolone was also rejected in 2021, and approval in 2022 is risky. See below for more details:
In 2022, the most anticipated new drugs are listed in the TOP10
Drug: Donanemab
Company: Eli Lilly
Indications: Alzheimer's disease
2026 sales: $6 billion
Donanemab is an antibody drug targeting β amyloid N3pG, ranking first among the most anticipated listed drugs in 2022. Similar to Bojian's new drug aducanumab approved in 2021, it is amyloid therapy.
Due to the controversial listing of aducanumab, and the difficulties encountered after the listing. Eli Lilly Pharma decided last year to conduct a positive clinical comparison trial with aducanumab, and it is expected that in the middle of next year, Eli Lilly will obtain data from the comparison trial with Aduhelm. Analysts at EvercoreISI believe that donanemab can reduce amyloid more than other similar drugs, including Aduhelm, which may give it a market advantage.
In addition, Eli Lilly plans to obtain the results of the Donanemab validated trial by 2023, three years ahead of Biogen, which expects to be unable to obtain data from the validation trial until 2026.
Eli Lilly has submitted Tonanemab for accelerated approval and expects to complete rolling submissions by the end of the first quarter of 2022. If all goes according to plan, donanemab is expected to be approved by the end of this year.
Drug: Tirzepatide
Indications: Diabetes
2026 sales: $4.9 billion
Tirzepatide is a GIP/GLP-1 dual receptor agonist developed by Eli Lilly for new drugs for type 2 diabetes. For the second new drug to be launched in 2022, the market potential sales will reach $4.9 billion in 2026.
It is worth mentioning that in 2021, Eli Lilly Tirzepatide beat Novo Nordisk's GLP-1 blockbuster Ozempic in a direct head-to-head clinical trial study. In the Phase 3 SURPASS-2 trial, Eli Lilly Tirzepatide outperformed Novo Nordisk's Ozepic at the highest approved dose in terms of lowering blood glucose levels and body weight in all three test doses.
However, some analysts believe that the advantages of tirzepatide "may not be enough to drive the transformation of the GLP-1 market". Publicly available data shows that Ozempic's annual revenue has reached around $3.4 billion and will peak at about $8 billion. Since its initial approval, a variety of indications have been approved. The challenges Tirzepatide will face are still enormous, but Eli Lilly is also working hard, both to expand the indications and to prepare for successful commercialization.
Drug: Gantenerumab
Company: Roche
2026 sales: $2.5 billion
Gantenerumab is a monoclonal antibody that targets β amyloid peptides. Originally developed by Morphosys, Roche was authorized to carry out a number of clinical studies, although repeated failures, Roche still insists on continuously adjusting the trial protocol to continue to move forward, there are still Phase 3 clinical trials underway, and it is expected to complete Phase 3 trials in the second half of 2022. In June 2020, Gantenerumab was licensed for clinical trials by CDE for the treatment of patients with prodromal to mild Alzheimer's disease.
It is worth mentioning that Gantenerumab is a similar drug with Bojian Aduhelm and Eli Lilly Donanemab. Due to its own controversy over the Alzheimer's amyloid hypothesis and the failure of many clinical trial studies, although the world's urgent demand for AD drugs, its competitive strength is not as good as Similar Drugs of Eli Lilly and Bojian. Sales in 2026 are expected to be less than half that of potential rivals, although they will still reach $2.5 billion in sales.
Drug: Deucravacitinib
Company: Bristol-Myers Squibb
Indications: Psoriasis
2026 sales: $2.4 billion
Deucravacitinib is a selective tyrosine kinase 2 (TYK2) inhibitor and the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies of multiple immune-mediated diseases. BMS has consistently listed it as a potential new oral drug to treat psoriasis, which is expected to shake up Otezla's leadership. BMS believes that Deubravacitinib's peak sales could exceed $4 billion, while EvaluateVantage expects its sales to reach $2.4 billion by 2026 in its 2022 preview report.
In addition, the FDA is expected to make a decision on the marketing approval of deutcravacitinib for psoriasis by September 10 this year. It is worth mentioning that in addition to psoriasis, Deucravacitinib has also conducted clinical research on a variety of autoimmune diseases, including psoriatic arthritis, lupus and inflammatory bowel disease.
Drug: Bardoxolone
Company: ReataPharmaceuticals
Indications: Chronic kidney disease (CKD) due to Alport syndrome
2026 sales: $2.2 billion
Bardoxolone is a small molecule Nrf2 activator for the treatment of chronic kidney disease (CKD) caused by Alport syndrome, there is currently no Alport syndrome therapy in the world, Bardoxolone may be the first blockbuster product on the market of the therapy, and has been listed in the top 10 list of the most anticipated drugs for two consecutive years.
According to public information, in April 2021, Reata submitted a listing application for Bardoxolone to the FDA, and at the same time launched the European application for approval. The final approval results will be obtained on February 25 this year.
It is worth noting that last December, the FDA expert review agency believed that Reata failed to prove that Bardoxolone can effectively slow the progression of CKD in patients with Alport syndrome; according to the data submitted by Reata, the benefits of the drug did not exceed its risks; therefore, it was upheld for Bardoxolone's approval, so it remains to be seen whether Bardoxolone can be successfully marketed this year!
Drug: Tezspire (tezepelumab-ekko)
Company: AstraZeneca/Amgen
Indications: Asthma
2026 sales: $2 billion
Tezepelumab, a monoclonal antibody that targets thymic interstitial lymphopoietin (TSLP), is the only biologic agent that does not have phenotypic (e.g., eosinophils or allergies) or biomarker restrictions; it provides a much-needed new treatment option for patients with severe asthma who have no control over their symptoms. On December 17, 2021, it was approved for the treatment of pediatric patients with severe asthma and adult patients aged ≥ 12 years.
Notably as an add-on maintenance treatment, Tezepelumab has the opportunity to challenge the dominance of Regeneron and Sanofi's blockbuster Dupixent. Tezepelumab sells for $47,229, which is more expensive, a full $10,000 more than Dupixent, launched in 2017. Still, a sales peak of $2 billion is expected in 2026.
Drug: Vutrisiran
Company: Alnylam
Indications: Treatment of hereditary transthyroxine protein amyloidosis multiple neuropathy (hATTR-PN) in adults
2026 sales: $1.8 billion
Vutrisiran is a researched, subcutaneous RNAi therapy for the treatment of hereditary (hATTR) and wild-type (wtATTR) ATTR amyloidosis. In previous III clinical trial results (HELIOS-A), Vutrisiran met the primary and all secondary endpoints, with statistically significant improvements in neuropathy, quality of life, and gait velocity, and showed good safety compared to the placebo combination Patisiran.
According to public information, in May 2020, Vutrisiran has been granted orphan drugs in the United States and the European Union (EU) and has been certified by the FDA Fast Track, and is expected to complete the approval on April 14 this year, and according to EvaluateVantage, Vutrisiran's sales in 2026 may reach $1.8 billion.
Drug: Mavacamten
Indications: Hypertrophic cardiomyopathy
2026 sales: $1.7 billion
Mavacamten, a targeted inhibitor of sarcomeretonin, is the first new drug in the category of selective allosteric inhibitors of myomyoglobulin ATPase, and in November 2020, Bristol-Myers Squibb acquired MyoKardia for approximately $13.1 billion.
It is worth mentioning that with the arrival of the patent cliff of the cardiovascular drug Eliquis, which Bristol-Myers Squibb and Pfizer jointly developed, mavacamten will be a blockbuster asset drug for its company's performance. BMS estimates that mavacamten's non-risk-adjusted revenue could exceed $4 billion in 2029. According to EvaluateVantage, its sales in 2026 will reach $1.7 billion.
Mavacamten was originally scheduled to be approved for marketing in November 2021, but the approval period was extended by 3 months as the FDA needed more time to evaluate the product safety of the drug.
Drug: Cilta-cel
Company: Johnson & Johnson/Legendary Creatures
Indications: Multiple myeloma
Cilta-cel is a BCMA-guided CAR-T cell therapy developed in collaboration with Johnson & Johnson and Legendary Biologics and is currently being developed to treat relapsed and/or refractory multiple myeloma (MM). It is the first Chinese-developed cell therapy to obtain FDA-approved clinical trials, and the first breakthrough therapeutic variety in China.
The FDA originally planned to approve the marketing of the cilta-cel drug on November 29, 2021, but later decided to extend it until February 28, 2022 due to a request to review additional information about the "updated analytical method". If approved, the drug will become the second CAR-T cell therapy to target BCMA on the market in the United States.
Although it faces many competitors, such as GlaxoSmithKline's approval of the BCMA-targeted antibody drug conjugate Blenrep in 2020, Bristol-Myers Squibb and Bluebird Bio's CAR-T therapy Abcema approved in March last year, it is estimated that its sales will still reach $1.7 billion in 2026.
Drug: Adgrasib
Company: Mirati Therapeutics
Indications: Non-small cell lung cancer
Adgrasib is an investigative, highly selective and potent oral small molecule inhibitor of KRASG12C, an innovative product for mirati Therati Theraeutics' upcoming commercialization, and a direct competitor to the KRAS drug Lumakras approved last year for the treatment of non-small cell lung cancer (NSCLC) with a specific genetic mutation called KRASG12C. It is considered by the industry to surpass Lumakras.
In addition, Adgrasib is being evaluated as a monotherapy and in combination with other anticancer therapies in patients with advanced KRASG12C mutant solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer, and pancreatic cancer. Sales are expected to reach USD 1.7 billion by 2026.
Resources:
1.Top10mostanticipateddruglaunchesof2022
2. Public information such as enterprise announcements
Responsible editor: Three seven
Disclaimer: This article is the content reproduced by Yaozhi Network, the copyright belongs to the original author, the purpose of reprinting is to convey more information, and does not represent the views of this platform. If it involves the content of the work, copyright and other issues, please contact this website, we will delete the content in the first time!