February 22, 2024

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Top 10 Highly Anticipated New Drugs Set to Hit the Global Market in 2024

Top 10 Highly Anticipated New Drugs Set to Hit the Global Market in 2024



Top 10 Highly Anticipated New Drugs Set to Hit the Global Market in 2024

A recent report by Evaluate has highlighted Karuna’s KarXT as the most promising drug of 2024 in terms of future potential, particularly in the rare victory against schizophrenia.

Additionally, Eli Lilly awaits FDA judgment on its donanemab, with competitors already on the market in the United States, and Moderna strives to launch its third RSV vaccine…

 

This article outlines the 10 heavyweight new drugs expected to hit the market in 2024, along with potential sales figures for 2028.

According to the statistics, these drugs are projected to generate a total sales revenue of $15.2 billion by 2028, with Karuna Therapeutics’ KarXT expected to lead with sales reaching $2.8 billion. Below are the specific details of each drug.

 

Top 10 Highly Anticipated New Drugs Set to Hit the Global Market in 2024

 

 


1. KarXT

KarXT is an investigational oral M1/M4 preferential muscarinic acetylcholine receptor agonist designed for treating psychiatric and neurological disorders, including mental symptoms in schizophrenia and Alzheimer’s disease.


In November of this year, Karuna Therapeutics announced that the U.S. FDA had accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of adult schizophrenia. The Prescription Drug User Fee Act (PDUFA) action date is set for September 26, 2024. If approved, KarXT will be the first new mechanism drug for treating schizophrenia in over a decade.


In December, the company published Phase III EMERGENT-2 clinical trial results in The Lancet, revealing clinically and statistically significant reductions in dominant symptoms (such as hallucinations and delusions) and latent symptoms in adult schizophrenia patients treated with KarXT, with overall good tolerability.


Currently, it is conducting a Phase III bridging registration clinical study to evaluate KarXT for schizophrenia in the domestic market. Additionally, this month, Bristol Myers Squibb reached a merger agreement with Karuna, with the acquisition price set at $14 billion.

 

2. Donanemab

Donanemab is an investigational monoclonal antibody being developed by Eli Lilly that binds to the N3pG subtype of β-amyloid protein, facilitating the clearance of β-amyloid plaques in the brains of Alzheimer’s patients, thereby improving symptoms and slowing disease progression.


In the second quarter of 2023, Lilly submitted a Biologics License Application (BLA) for Donanemab to the FDA. Apart from the U.S., Lilly plans to sequentially submit market applications for the drug in other global markets, with most submissions expected to be completed by the end of the year. Consulting firms predict peak sales for Donanemab to exceed $6 billion.

 

3. Resmetirom

Resmetirom, developed by Madrigal Pharmaceuticals, is an oral small molecule liver-targeted, selective thyroid hormone receptor β (THR-β) agonist and the first drug to achieve the primary endpoints in a Phase III clinical trial in the NASH treatment field.


In April 2023, Resmetirom received breakthrough therapy designation from the FDA. In July, the company announced a rolling submission of the New Drug Application (NDA) to the FDA for the treatment of NASH in adults with liver fibrosis, applying for priority review. In September, the FDA accepted the NDA, granting it priority review status. The drug is expected to become the first FDA-approved treatment for non-alcoholic steatohepatitis (NASH).

 

4. Sotatercept

Sotatercept is a potential first-in-class IIA activin receptor (ActRIIA) fusion protein. It combines the modified extracellular domain of ActRIIA with the Fc portion of an antibody, blocking the binding of activin to receptors on the cell membrane, thereby reducing activin-mediated signaling. The drug was acquired by Merck for $11.5 billion in September 2021.


Currently, Sotatercept has received breakthrough therapy designation and orphan drug designation from the FDA, as well as priority medicinal product designation and orphan drug designation from the European Medicines Agency for the treatment of pulmonary arterial hypertension (PAH). Notably, it is the first PAH investigational therapy to receive breakthrough therapy designation. The PDUFA date is set for March 26, 2024.

 

5. Datopotamab Deruxtecan

Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 mAb linked covalently to a stable tumor-selective tetrapeptide and a topoisomerase I inhibitor payload.


In September of this year, AstraZeneca and Daiichi Sankyo jointly announced that in a Phase III clinical trial for treating inoperable or metastatic HR-positive, HER2-low or negative breast cancer, datopotamab deruxtecan demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) compared to investigator-selected chemotherapy. The drug is expected to be declared for market approval in 2024.

Additionally, globally, the two companies have initiated over 12 clinical trials evaluating datopotamab deruxtecan’s effectiveness in various cancer types, including non-small cell lung cancer, triple-negative breast cancer, and HR-positive, HER2-low or negative breast cancer.

 

6. Acoramidis

Acoramidis is a next-generation oral transthyretin (TTR) stabilizer under development for treating ATTR-CM. It aims to effectively stabilize tetrameric transthyretin protein (TTR) from the outset to prevent a series of molecular events leading to transthyretin amyloidosis (ATTR).


On July 17th, BridgeBio announced positive results from the Phase III ATTRibute-CM study of Acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). The study’s primary endpoint indicators (in prioritized sequential hierarchy: all-cause mortality, cardiovascular-related hospitalization frequency, change in NT-proBNP from baseline, change in 6-minute walk distance from baseline) showed highly statistically significant improvement with a Win Ratio of 1.8 (p < 0.0001).

The survival rate after treatment was 81% (compared to 74% in the placebo group), with an absolute risk reduction of 6.43% and a relative risk reduction of 25%. The relative risk of cardiovascular-related hospitalization decreased by 50% (p < 0.0001), with high statistical significance.

 

7. mRNA-1345

mRNA-1345 is a single-dose mRNA vaccine encoding the prefusion F glycoprotein of RSV, inducing a higher neutralizing antibody response compared to the postfusion state. mRNA-1345 uses the same lipid nanoparticles (LNP) as Moderna’s COVID-19 vaccine, containing optimized protein and codon sequences.


In July of this year, Moderna announced the global market application submission for RSV mRNA vaccine mRNA-1345, including applications to the EU, Switzerland, and Australia, with a rolling submission already initiated to the FDA. The FDA is expected to make an approval decision in April next year.

 

8. Anktiva

Anktiva is a fusion protein-binding cytokine complex drug developed by ImmunityBio subsidiary Altor BioScience, belonging to the IL-15 agonist class, consisting of IL-15 variant (IL-15 N72D) and IL-15Rα chain fused with Fc domain. IL-15 is a multifunctional cytokine that plays a core role in the development, survival, and activation of NK, T, and B cells.


In December 2019, Anktiva received FDA breakthrough therapy designation for non-muscle-invasive bladder cancer. In May 2022, ImmunityBio submitted Anktiva’s BLA to the FDA for use in combination with BCG in the treatment of non-muscle-invasive bladder cancer (NMIBC) unresponsive to BCG.

However, due to defects in the third-party contract manufacturer, the application was rejected by the FDA. In October 2023, the FDA accepted the resubmitted BLA for Anktiva from ImmunityBio, with a PDUFA action date of April 23, 2024.

 

9. Ensifentrine

Ensifentrine is a potential first-in-class phosphodiesterase 3/4 (PDE3/4) inhibitor, achieving both bronchodilation and anti-inflammatory effects with a dual inhibitory mechanism.

In June of this year, Verona Pharma announced the submission of the New Drug Application (NDA) for Ensifentrine to the U.S. FDA as a maintenance therapy for chronic obstructive pulmonary disease (COPD) patients. If approved, it could become the first new mechanism therapy for COPD in over a decade.

In June 2021, Union Medical Pharmaceuticals acquired the Greater China rights for Ensifentrine for $40 million upfront plus $179 million in milestone payments. Currently, it is conducting Phase I and III clinical trials in China.

 

10. Imetelstat

Imetelstat is an investigational telomerase inhibitor that binds to and inhibits the activity of telomerase, designed to block the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies such as myelodysplastic syndromes (MDS) and myelofibrosis (MF).


In August of this year, Geron Corporation announced that the FDA had accepted the New Drug Application (NDA) for Imetelstat for the treatment of transfusion-dependent anemia in low-risk MDS patients. Geron has requested FDA approval for priority review of the application. Additionally, the company expects to submit a Marketing Authorization Application (MAA) to the European Union (EU) in the fourth quarter of 2023.

Top 10 Highly Anticipated New Drugs Set to Hit the Global Market in 2024

(source:internet, reference only)


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