As we embark on the pharmaceutical landscape of 2024, the anticipation is palpable for groundbreaking drug launches that promise to reshape the treatment landscape for various conditions. Let’s delve into the top 10 most anticipated drug launches of the year, each holding the potential to make a significant impact.
1. KarXT: Revolutionizing Schizophrenia Treatment
Drug: KarXT
Company: Karuna Therapeutics
Used for: Schizophrenia
Est. 2028 sales: $2.8 billion
In an unexpected turn, Karuna Therapeutics emerges as a frontrunner with its revolutionary drug, KarXT, challenging the conventional expectations of blockbuster sales. Acquired by Bristol Myers Squibb for a staggering $14 billion, this first-in-class M1/M4 muscarinic receptor agonist aims to address the underserved market of schizophrenia. With a robust safety profile and unprecedented efficacy, KarXT presents a potential game-changer in the field.
Karuna’s approach focuses on treating the severity of schizophrenia, backed by compelling data from three placebo-controlled studies. The company’s unique advantages lie in the drug’s efficacy and minimal side effects, differentiating it from existing treatments plagued by issues like drowsiness and weight gain. With a PDUFA date set for September 25, 2024, the industry eagerly awaits Bristol Myers Squibb’s responsibility to unleash KarXT’s projected $2.8 billion sales potential by 2028.
2. Donanemab: Paving the Way for Alzheimer’s Treatment
Drug: Donanemab
Company: Eli Lilly
Used for: Alzheimer’s disease
Est. 2028 sales: $2.2 billion
Eli Lilly’s Donanemab resurfaces as a highly anticipated drug launch after overcoming regulatory hurdles. Initially topping the charts in 2022 with a projected $6 billion in sales by 2026, the drug’s journey faced setbacks, including an FDA rejection in 2023. However, Lilly’s persistence pays off, with a refiled application and expectations of FDA decision in the first quarter of 2024.
As the Alzheimer’s treatment landscape recalibrates post-Aduhelm, Donanemab strives to establish itself as a contender. Lilly’s recent data showcases promising results, including a 35% slowing of cognitive decline and a 39% lower risk of disease progression compared to placebo. With anticipated sales of $2.2 billion by 2028, Donanemab aims to provide a meaningful alternative in a market regaining confidence.
3. Resmetiron: Breaking Ground in NASH Treatment
Drug: Resmetiron
Company: Madrigal Pharmaceuticals
Used for: Nonalcoholic steatohepatitis
Est. 2028 sales: $2.1 billion
Madrigal Pharmaceuticals enters the spotlight with Resmetiron, aiming to succeed where many have faltered in treating nonalcoholic steatohepatitis (NASH). With a prevalence estimated at 6.5% of the U.S. adult population, NASH presents a significant health concern associated with obesity and type 2 diabetes.
Resmetiron, a THR-β agonist, demonstrated positive phase 3 results, offering hope for a safe and effective NASH treatment. The drug’s potential $2.1 billion in sales by 2028 signifies a resurgence of confidence in the NASH research landscape after a series of trial setbacks.
4. Sotatercept: Advancing Pulmonary Arterial Hypertension Treatment
Drug: Sotatercept
Company: Merck & Co.
Used for: Pulmonary arterial hypertension
Est. 2028 sales: $2 billion
Merck & Co. returns to the list with Sotatercept, an experimental drug for pulmonary arterial hypertension (PAH). Unlike its vasodilator counterparts, Sotatercept, an activin receptor type IIA-Fc fusion protein, directly targets the proteins underlying PAH. With a PDUFA date set for March 26, 2024, Merck anticipates a significant market impact, given the drug’s potential as a first-in-class PAH treatment.
The excitement surrounding Sotatercept stems from its unique mechanism and potential advantages over existing PAH drugs. As Merck seeks to diversify beyond Keytruda, this drug’s projected $2 billion in sales by 2028 holds strategic importance for the pharmaceutical giant.
5. Datopotamab Deruxtecan: AstraZeneca’s Bet on ADCs
Drug: Datopotamab Deruxtecan
Companies: Daiichi Sankyo/AstraZeneca
Used for: Lung and breast cancers
Est. 2028 sales: $1.8 billion
AstraZeneca and Daiichi Sankyo collaborate on Datopotamab Deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC) designed to target lung and breast cancers. Positioned as the successor to Enhertu, Dato-DXd aims to capitalize on the success of ADCs in treating various cancers.
The drug’s promising results in advanced or metastatic solid tumors, including durable responses in lung and breast cancers, have garnered attention. With an estimated $1.8 billion in sales by 2028, Dato-DXd represents AstraZeneca’s strategic move to expand its oncology portfolio and strengthen its position in the competitive ADC landscape.
6. Faricimab: Roche’s Dual Threat Against Eye Diseases
Drug: Faricimab
Company: Roche/Genentech
Used for: Wet age-related macular degeneration and diabetic macular edema
Est. 2028 sales: $1.6 billion
Roche, in collaboration with Genentech, introduces Faricimab, a novel bispecific antibody designed to target multiple pathways implicated in eye diseases. Positioned as a dual threat against wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), Faricimab has the potential to disrupt the current treatment landscape.
The drug’s distinct mechanism of action, targeting both angiopoietin-2 and vascular endothelial growth factor (VEGF), sets it apart from existing therapies. With positive phase 3 results demonstrating non-inferiority to aflibercept, Faricimab aims for regulatory approval in 2024. The estimated $1.6 billion in sales by 2028 reflects Roche’s strategic vision to capture a substantial share of the ophthalmology market.
7. Tislelizumab: Bridging Gaps in Oncology
Drug: Tislelizumab
Company: BeiGene
Used for: Various cancers
Est. 2028 sales: $1.5 billion
BeiGene’s Tislelizumab, a programmed death receptor-1 (PD-1) inhibitor, emerges as a promising player in the competitive field of immuno-oncology. The drug, designed to unleash the body’s immune system against cancer cells, stands out with its potential to bridge gaps in treating various cancers.
With an expanded indication range covering hepatocellular carcinoma (HCC) and esophageal squamous cell carcinoma (ESCC), Tislelizumab aims to secure a solid position in the oncology landscape. The estimated $1.5 billion in sales by 2028 reflects the drug’s potential to capture a meaningful share of the PD-1 inhibitor market, challenging established players like Keytruda and Opdivo.
8. Aklief (trifarotene) Foam: Galderma’s Innovation in Acne Treatment
Drug: Aklief (trifarotene) Foam
Company: Galderma
Used for: Acne
Est. 2028 sales: $1.3 billion
Galderma’s Aklief (trifarotene) Foam disrupts the acne treatment landscape with its innovative approach to topical retinoid therapy. Positioned as a first-in-class trifarotene foam, Aklief presents a novel treatment option for moderate to severe acne, targeting both inflammatory and non-inflammatory lesions.
The drug’s unique formulation offers a favorable safety profile and convenience, addressing concerns associated with traditional retinoid treatments. With an estimated $1.3 billion in sales by 2028, Aklief aims to establish itself as a preferred choice among dermatologists and patients seeking effective and well-tolerated acne solutions.
9. Givosiran: Expanding Options in Acute Hepatic Porphyria
Drug: Givosiran
Company: Alnylam Pharmaceuticals
Used for: Acute hepatic porphyria
Est. 2028 sales: $1.2 billion
Alnylam Pharmaceuticals enters the spotlight with Givosiran, a first-in-class RNA interference (RNAi) therapeutic for the treatment of acute hepatic porphyria (AHP). With a unique mechanism targeting aminolevulinic acid synthase 1 (ALAS1), Givosiran aims to reduce neurotoxic heme intermediates and prevent recurrent attacks associated with AHP.
The drug’s positive results in phase 3 studies position it as a promising option for patients with limited treatment choices. Alnylam anticipates Givosiran’s sales to reach $1.2 billion by 2028, reflecting the drug’s potential to fill a critical gap in the management of AHP.
10. Zandelisib: Enhancing Options in Hematologic Malignancies
Drug: Zandelisib
Company: MEI Pharma/BTG Specialty Pharmaceuticals
Used for: Hematologic malignancies
Est. 2028 sales: $1 billion
MEI Pharma and BTG Specialty Pharmaceuticals join forces with Zandelisib, an investigational phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor targeting hematologic malignancies. With a focus on relapsed or refractory follicular lymphoma and marginal zone lymphoma, Zandelisib aspires to offer a valuable addition to the treatment armamentarium for these challenging conditions.
The drug’s promising efficacy and safety profile position it as a contender in the competitive landscape of hematologic malignancies. The estimated $1 billion in sales by 2028 reflects Zandelisib’s potential to carve out a niche in the rapidly evolving field of targeted therapies for blood cancers.
Note: Estimated sales figures are based on industry analyses and may be subject to change as market dynamics evolve.
