Ten Highly Anticipated Blockbuster Therapies Expected for Approval in 2024

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Edited by Kant Content Team

Recently, EvaluatePharma, an industry media, released an analysis report on the trends of the biopharmaceutical industry in 2024, which included coverage of key therapies that may be approved for marketing in 2024.Today, the WuXi AppTec content team will introduce these potential blockbuster therapies that could be approved this year based on the report and publicly available information.

Image Source: 123RF

The report mentions that the rare positive clinical outcomes achieved in the field of schizophrenia have made KarXT one of the most anticipated potential blockbuster therapies in 2024.And Alzheimer's disease (AD) will continue to be the industry focus in 2024.Currently, Eli Lilly and Company's AD therapy donanemab is under review by the U.S. FDA, with results expected to be announced earlier this year. Additionally, Madrigal Pharmaceuticals is also awaiting the FDA's review of resmetirom.If approved, this would be the first therapy for non-alcoholic steatohepatitis (NASH) to receive FDA approval.

Meanwhile, following GSK and Pfizer, Moderna is also working on launching the third Respiratory Syncytial Virus (RSV) vaccine. In the field of oncology, datopotamab deruxtecan, an investigational antibody-drug conjugate (ADC) targeting Trop2 and jointly developed by AstraZeneca and Daiichi Sankyo, has shown positive results in Phase 3 trials for both lung and breast cancer, and is also expected to be approved for marketing this year.

▲Overview of Potential Blockbuster Therapies Expected to Be Approved in 2024 (Chart Source: WuXi AppTec Content Team, Reorganized and Tabulated Based on Reference [1])

It is worth noting that,Among the 10 potential blockbuster drugs mentioned in this report, small molecule drugs account for five.Two of the drugs are protein-based, andMonoclonal antibodies, ADCs, and mRNA vaccines each account for one product. This result shows that small-molecule drugs will still play an important and indispensable role in the biopharmaceutical field in 2024.

Ten Promising Therapies Expected to Be Approved in 2024

Therapy:

KarXT（xanomeline-trospium）

Company:

Bristol-Myers Squibb

Development Status:

PDUFA Date is September 26, 2024

KarXT is an investigational oral M1/M4 muscarinic acetylcholine receptor agonist developed by Karuna Therapeutics. In December 2023, Karuna reached an agreement with Bristol-Myers Squibb.Acquisition Agreement

The latter has thus obtained this potential "first-in-class" therapy. KarXT is currently being developed for the treatment of mental and neurological disorders, including schizophrenia and as an adjunctive treatment for Alzheimer's disease psychosis. According to the press release, if approved, KarXT will become the first new mechanism drug for treating schizophrenia in decades.

▲Primary Endpoint Results of KarXT in the EMERGENT-3 Clinical Trial (Image Source:

Karuna Company Official Website)

Therapy:

Donanemab

Company:

Eli Lilly

Development Status:

The company expects to announce the FDA review results in the first quarter of 2024.

Donanemab is a monoclonal antibody targeting β-amyloid protein. It met the primary endpoint in a Phase 2 clinical trial, slowing the clinical progression rate of early Alzheimer's disease patients by 32%.

In biomarker research, donanemab not only leads to the rapid clearance of amyloid plaques but also significantly reduces the level of P-tau217 in patients' plasma. This is an investigational blood biomarker developed by Eli Lilly, associated with amyloid and tau pathology, as well as the diagnosis of Alzheimer’s disease (AD). Even one year after discontinuing donanemab treatment, the level of P-tau217 remains significantly reduced. The FDA has granted Priority Review status to the Biologics License Application (BLA) for donanemab.

▲The reduction in amyloid plaque and P-tau217 levels was still maintained one year after discontinuation of Donanemab (Image source: Eli Lilly's official website)

Therapy:

Resmetirom

Company:

Madrigal Pharmaceuticals

Development Status:

PDUFA Date is March 14, 2024

Resmetirom is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target the key underlying causes of NASH.

Thyroid hormones play a central role in liver function by activating β-receptors in hepatocytes, influencing a range of health parameters from serum cholesterol and triglyceride levels to pathological fat accumulation in the liver. Resmetirom is highly selective, avoiding the activation of THR-α receptors that mediate thyroid hormone activity outside the liver (including in the heart and bones), and is specifically taken up in the liver. In clinical trials,

The vast majority (>70%) of patients treated with 100 mg resmetirom achieved ≥30%

Proton Density Fat Fraction (MRI-PDFF) Relief.

Notably, a reduction of ≥30% in MRI-PDFF was closely associated with NASH resolution (96% of patients) and fibrosis improvement (88% of patients). In September 2023, the U.S. FDA granted priority review status to this therapy for the treatment of NASH.

▲

Efficacy Results of the MAESTRO-NASH Trial (Image Source: Reference [2])

Therapy:

Sotatercept

Company:

MSD

Development Status:

PDUFA Date is March 26, 2024

Sotatercept is a potential "first-in-class" type IIA activin receptor (ActRIIA) fusion protein.

It fuses the modified extracellular domain of ActRIIA with the Fc portion of an antibody. It can block activin from binding to receptors on the cell membrane, thereby reducing activin-mediated signaling.

Otatercept Achieves Primary Endpoint in Phase 3 Clinical Trial STELLAR

Compared with placebo, it brought a statistically significant and clinically meaningful improvement in patients' 6-minute walk distance (6MWD). It has received the FDA's Breakthrough Therapy designation, and this is also the first investigational therapy for pulmonary arterial hypertension to receive the Breakthrough Therapy designation.

▲Sotatercept adjusts the balance between promoting and inhibiting hyperplasia signals (Image source:

MSD Official Website）

Therapy:

Datopotamab deruxtecan

Company:

Daiichi-Sankyo & AstraZeneca

Development Status:

The company expects to submit the therapy for the treatment of lung cancer and breast cancer to regulatory authorities in the United States and Europe, with the review results expected in 2024.

Datopotamab deruxtecan is an ADC composed of a humanized, Trop2-targeting monoclonal antibody linked to an innovative DNA topoisomerase I inhibitor (DXd).

DXd has a unique mechanism of action, with 10 times higher activity compared to the common chemotherapy drug irinotecan. Moreover, this drug has a strong ability to penetrate cell membranes, enabling it to kill neighboring cancer cells after destroying ADC-ingesting cancer cells, producing a "bystander effect." This was disclosed at the European Society for Medical Oncology (ESMO) Congress in October 2023.Test Results

Results showed that, compared with active drugs, the ADC therapy significantly reduced the risk of disease progression or death in patients with advanced non-small cell lung cancer (NSCLC) and inoperable or metastatic HR-positive, HER2-low or negative breast cancer in two Phase 3 trials.

Therapy:

Acoramidis

Company:

BridgeBio Pharma

Development Status:

The company submitted a new drug application to the FDA in December 2023.

Acoramidis is a new generation, orally administered, highly efficient transthyretin (TTR) small molecule stabilizer.

It aims to simulate the function of the protective TTR T119M mutation, maintaining the normal tetrameric conformation of TTR protein and preventing the production of toxic amyloid proteins. It is under development for the treatment of patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). The company's phase 3 trial results, published in July of last year, showed that the therapy achieved a highly statistically significant improvement in the primary endpoint. The survival rate during the treatment period in the Acoramidis group was 81% (compared to 74% in the placebo group), which began to approach the estimated life expectancy of the population without ATTR-CM (historically, the survival rate of this population is 85%). Absolute risk reduction was 6.43%, with a relative risk reduction of 25%.

▲

Mechanism of Action of Acoramidis (Image Source: Reference [3])

Therapy:

mRNA-1345

Company:

Moderna

Development Status:

Submitted Marketing Application to Global Regulatory Authorities

mRNA-1345 is an mRNA vaccine that encodes the virus's stabilized pre-fusion F glycoprotein, which can elicit a superior neutralizing antibody response compared to the post-fusion state.

It uses the same lipid nanoparticle (LNP) delivery system as Moderna's COVID-19 vaccine and contains optimized protein and codon sequences. The key trial of this vaccine met two primary efficacy endpoints, targeting symptoms defined by two or more criteria.

The vaccine efficacy against RSV-associated lower respiratory tract disease (RSV-LRTD) is 83.7%, and the vaccine efficacy for RSV-LRTD defined by three or more symptoms is 82.4%. The U.S. FDA has granted mRNA-1345 Fast Track designation and Breakthrough Therapy designation to help prevent RSV-LRTD and acute respiratory disease (ARD) in adults aged 60 years or older.

Therapy:

Anktiva（N-803）

Company:

ImmunityBio

Development Status:

PDUFA Date is April 23, 2024

Anktiva is a superagonist of interleukin-15 (IL-15).

IL-15 Plays a Crucial Role in the Immune System by Influencing the Development, Maintenance, and Function of Natural Killer (NK) Cells and Cytotoxic T Cells. Anktiva Consists of an IL-15 Mutant (IL-15N72D) Bound to an IL-15 Receptor α/IgG1 Fc Fusion Protein. It Specifically Stimulates CD8-Positive T Cells and NK Cells via Binding to the βγT Cell Receptor While Avoiding Stimulation of Regulatory T Cells (Tregs). Compared with Native, Non-Complexed IL-15, Anktiva Exhibits Superior Pharmacokinetic Properties in Patients, Longer Persistence in Lymphoid Tissues, and Enhanced Antitumor Activity. When Combined with Bacillus Calmette-Guérin (BCG), This Therapy Achieved the Primary Endpoint in Phase 2/3 Clinical Trials for Treating Papillary Subtype Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) Who Are BCG-Unresponsive, with 57% of Patients Achieving 12-Month Disease-Free Survival (DFS).

  

▲Mechanism of Action of Anktiva (Image Source: Reference [4])

Therapy:

Ensifentrine

Company:

Verona Pharma

Development Status:

PDUFA Date is June 26, 2024

Ensifentrine is a potential "first-in-class" phosphodiesterase 3/4 (PDE3/4) inhibitor. Its dual inhibition mechanism enables it to achieve both bronchodilation and anti-inflammatory effects simultaneously with a single compound.

Verona Pharma assessed the efficacy of nebulized ensifentrine as a maintenance therapy for chronic obstructive pulmonary disease (COPD) in two Phase 3 clinical trials, ENHANCE-1 and ENHANCE-2. Ensifentrine met the primary endpoint in both trials, demonstrating statistically significant and clinically meaningful improvements in lung function. A pooled analysis of the ENHANCE-1 and ENHANCE-2 trials showed that ensifentrine substantially reduced the risk of COPD exacerbations. If approved, this therapy could become the first new mechanism treatment for COPD in over a decade.

▲Chemical structure of Ensifentrine (Image source: PubChem)

Therapy:

Imetelstat

Company:

Geron

Development Status:

PDUFA Date is June 16, 2024

Imetelstat is a potential "first-in-class" telomerase inhibitor in development for the treatment of hematologic malignancies.

Imetelstat is being developed for the treatment of adult patients with transfusion-dependent anemia who are non-responsive or resistant to erythropoiesis-stimulating agents (ESAs), or ineligible for ESAs, and who have myelodysplastic syndromes (MDS, low to intermediate-1 risk). The submission of its marketing application is primarily based on the results of the IMerge Phase 3 clinical trial, where the primary endpoint was the rate of maintaining 8-week transfusion independence (TI). This rate was significantly higher in the imetelstat group compared to the placebo group (P<0.001), with a median TI duration of nearly one year among responders (maintaining 8-week TI) to imetelstat. Compared to patients receiving placebo, the mean hemoglobin levels of patients treated with imetelstat increased significantly over time (P<0.001).

▲I

Top-line Data from Phase 3 Clinical Trial of Metelstat (Source: Reference [5])

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References:

[1] Will biopharma find its footing? 2024Preview. Retrieved December 29, 2023 from https://www.evaluate.com/thought-leadership/pharma-reports/2024-preview-report?utm_source=website&utm_medium=banner&utm_campaign=2024_preview&utm_content=ebook

[2] Primary Results From MAESTRO-NASH: A Pivotal Phase 3 52-week Serial Liver Biopsy Study in 966 Patients With NASH & Fibrosis. Retrieved November 10, 2023 from https://ir.madrigalpharma.com/static-files/e8a35f47-f841-49d4-9c21-781f41177609

[3] BBIO - ATTRibute-CM Detailed Results From ESC Congress 2023. Retrieved August 28, 2023 from https://investor.bridgebio.com/static-files/f3645003-5c8f-4ec2-b943-03bbad0c156e

[4] 39th Annual JP Morgan Healthcare Conference. Retrieved February 16, 2021, from https://immunitybio.com/wp-content/uploads/2021/02/2021.01.13-JP-Morgan-Presentation-2021-v6sm-Final-1.pdf

[5] Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat. Retrieved June 20, 2023 from https://ir.geron.com/investors/press-releases/press-release-details/2023/Geron-Announces-Submission-of-New-Drug-Application-to-FDA-for-First-in-Class-Telomerase-Inhibitor-Imetelstat/default.aspx

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div.autoTypeSetting24psection > p,div.autoTypeSetting24psection > section{margin-bottom: 24px;}