Top Performing Drug – Dupixent (April Edition)

Shots:

In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Dupixent and prepared a curated analysis report for our readers
Dupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc.
PharmaShots presents an informative take on the key features of Dupixent with a detailed analysis of its revenue, clinical trials, alternatives, and approvals. The report is concluded with an engaging SWOT analysis and edifying KOL reviews

Active Ingredient: Dupilumab

Dosage Forms & Strengths:

Single-Dose Pre-Filled Syringe with Needle Shield

Injection: 300 mg/2 mL, 200 mg/1.14 mL, 100 mg/0.67 mL

Single-Dose Pre-filled pen

Injection: 300 mg/2 mL, 200 mg/1.14 mL

Mechanism of Action: interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor

First Approvals: FDA (Mar 28, 2017), EC (Sep 27, 2017), NMPA (Jun 19, 2020), MHLW (Jan 22, 2018)

Originator: Sanofi & Regeneron

Revenue Analysis¹

Dupixent is developed and commercialized in collaboration with Regeneron. Under the collaboration agreement, Sanofi records product sales for commercialized products, while Regeneron gets the right to co-commercialize such products on a country-by-country basis. Both companies collaborated on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody License and Collaboration Agreement, Sanofi is responsible for funding 80% to 100% of the agreed-upon development costs. Regeneron reimburses 50% of cumulative development costs quarterly. According to the amendment in the agreement on July 1, 2022, Regeneron’s share of profits for development costs increased from 10% to 20%.

Dupixent has been Sanofi’s major product in terms of sales, accounting for 19.3% of its total sales for 2022. Below is the graphical representation analysis of the past five years of Dupixent sales from Sanofi.

*International sales included sales from Europe and other countries.

Approved Indications for Dupixent²

Dupixent is approved for the treatment of:

Moderate-to-severe atopic dermatitis
Moderate-to-severe eosinophilic or oral steroid-dependent asthma (Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus)
Chronic rhinosinusitis with nasal polyposis (CRSwNP).
Eosinophilic esophagitis (EoE)
Prurigo nodularis

Clinical Trials Analysis³

Dupixent underwent 184 trials, incl. 137 industry trials, 114 of which were interventional, 22 observational, and 1 expanded access trial.

PharmaShots' analysis of Dupixent’s industry trials is depicted below: (Trials were taken on 29 Mar 2023).

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

*Planned trials include Not, yet recruiting

Dupixent Trials Representation (Country-wise)⁴

Presently, Dupixent is being evaluated under different indications across the globe. The stacked column chart below is a visual representation of the clinical trials conducted with Dupixent so far. We have showcased active clinical trials of the top 10 countries worldwide. (The chart depicts data till April 13th, 2023)

* Besides the data shown in the chart, 13 countries have double-digit trial numbers, and 28 countries with single-digit trial numbers. For a detailed report on it, mail us at connect@pharmashots.com

Product Dashboard

PharmaShots has done a visual representation of Dupixent key metrics and data through its product dashboard.

Dupixent Alternative Drugs⁵

In response to Dupixent, several other drugs are available in the market and are used to treat different indications. Some of the alternative drugs for Dupixent include:

Dupixent Pipeline Analysis⁶

PharmaShots presents a thorough analysis of the Dupixent pipeline, including ongoing Phase II and Phase III registration studies for various indications. The table shown below is an overview of the status of these studies

Dupixent SWOT Analysis⁷

Strenghts

Unique Mechanism of Action: Dupixent has a unique mechanism of action targeting the type 2 inflammation pathway. This MoA makes it different from other medications in similar indications
Convenient Drug: Dupixent, being a self-administrating drug, comes as a pre-filled syringe and as a pre-filled pen, making it a handy therapy option
Growing Potential: Dupixent is available in all major markets, such as the US, the European Union countries, and Japan, thus, securing a viable spot in the growing market for biological drugs
Spurring Demand: With a spike in the prevalence of atopic dermatitis and asthma, the demand for Dupixent is at an all-time high. As it is approved for both moderate-to-severe eczema and moderate-to-severe asthma, it is one of the recognized treatment options
High efficacy: Insights derived from clinical trials and data, showed Dupixent as an effective drug for the treatment of eczema and asthma
- In adults with eczema, the clinical study showed half of the patients with 75% improvement in their skin post-treatment. Moreover, the study showed 36% to 39% of people with clear or almost-clear skin at the end of 16 weeks
- On May 17, 2021, clinical results from the Phase III trial showed that patients exhibited a considerable reduction in severe asthma attacks. The results also showed significant improvement in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation
Multiple lines of Action: Dupixent is approved around multiple lines of extension as mentioned below:

Atopic dermatitis

In Aug 2019, approved in Europe for the treatment of adolescents aged 12 to 17 years
In Sep 2021, approved in China for the treatment of adolescents aged 12-17 years
In May 2020, approved in the US for the treatment of children aged 6 months to 11 years.
In Feb 2022, approved in China for the treatment of children aged 6-11 years
In Jun 2022, approved in the US for the treatment of children aged 6 months to 5 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Asthma:

In Oct 2021, approved in the US as an add-on maintenance treatment for patients aged 6 to 11 years
In Apr 2022, approved in the EU for children aged 6 to 11 years with severe asthma with type 2 inflammation

Eosinophilic esophagitis

In May 2022, approved in the US for children aged 12 years and older In Jan 2023 approved in Europe for the treatment of patients aged 12 years and older

Chronic rhinosinusitis with nasal polyposis

In Jun 2019, approved in the US for use with other medicines for the treatment of adults whose disease is not controlled
In Oct 2019, approved in Europe for use as an add-on therapy with intranasal corticosteroids in adults with severe CRSwNP

Prurigo Nodularis

In Dec 2022, approved in Europe to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy

Weaknesses

High Cost & Limited Accessibility: Being biologic, it is rather difficult to replicate the generic form of Dupixent. Therefore, making it a bit expensive with limited accessibility
Limited Administration Formulations: Dupixent is a subcutaneous, injectable drug, which makes it inconvenient for some patients who are prone to allergic reactions and are trypanophobic
Side effects: Dupixent may incur mild to serious side effects in patients, such as allergic reactions, eye problems, and injection site reactions

Opportunities

New indications: Owing to the versatility of Dupixent, it is now being evaluated for multiple indications, such as chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis under different studies to expand its market in the future
Possibility of global expansion: Due to the global prevalence of asthma and atopic dermatitis, there is a huge potential for Dupixent to assert global market dominance
Various combinations with other drugs: Dupixent can also be used in combination with other drugs to enhance the overall efficacy

Threats

Competitors: Other alternatives, such as Humira, Cosentyx & Xolair with distinct formulations can limit its market profit
Biosimilar drugs: Post Dupixent's patent expiry, there's a prospect of low-cost biosimilars entering the market, affecting its revenue
Regulatory Challenges: With the transient nature of government’s rule, the advent of new reforms is a higher possibility. Hence, regulatory challenges and delays can impact Dupixent's ability to infuse into new indications or across the geography
Reimbursement restrictions: Reimbursement restrictions and formulary placement may impact patients' access to Dupixent, particularly in regions with limited healthcare budgets

Patient Stories⁸

Patients' stories have been instrumental in sharing their perspectives on individual experiences in facing health challenges. These are a few key resources to understand healthcare services and policies. Some of the patients’ stories for Dupixent are mentioned below:

MARK'S STORY: Mark underwent various treatments like steroids, antibiotics, and surgery for his nasal polyps but found no relief. After discussing with his doctor and conducting some independent research, he discovered that DUPIXENT might be the solution to manage his symptoms. He says “I did some research on my own, thought about it, and decided to give it a try.”
TIM’S STORY: Tim's severe asthma hindered his participation in activities and working on his family farm. Despite trying various treatments, he could not control his asthma. Following a recommendation from his asthma specialist, Tim started using Dupixent. He says “Now, I’m on DUPIXENT, and I’m able to DU MORE of the things I like to do. I’m still careful to avoid my asthma triggers, but I am able to be more active”
ARSALAN’S STORY: Arsalan was living with moderate-to-severe atopic dermatitis since 6 years of age. He says “I needed a long-term option. My arms were constantly itching. Topical Rxs didn't help. Dupixent does.”

Watch out for more patient stories on www.dupixent.com/

KOL* Reviews⁹

KOL reviews are valuable resources for any drug to increase its reach and reliability. Generally, these reviews are helpful when consumers research the product and read multiple reviews before buying it. Below are some of the KOL reviews for Dupixent.

In Mar 2023, positive results from the clinical trial assessing Dupixent in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented at the AAD 2023 Annual Meeting.

Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University and principal investigator of the trial said “In this trial, Dupixent significantly improved disease signs, symptoms, and quality of life measures for this particularly difficult-to-treat subset of atopic dermatitis patients, with itch improvement seen as early as one week after the first dose. While the efficacy and safety profile of Dupixent is well-established for atopic dermatitis more broadly, these positive results are the first demonstrating the impact on specific and heavily used areas of the body.”

In Aug 2022, in a Spotlight review session by Contemporary Pediatrics on the Role of Disease-Modifying Therapies for Atopic Dermatitis Treatment, Elizabeth Swanson, MD, Dermatologist, and St Luke’s health partner said “I will think of my career in treating people with atopic dermatitis as BD, before dupilumab, and AD, after dupilumab, because it has revolutionized the treatment paradigm and what we can achieve for our patients in a safe way.”
In Mar 2023, Dupixent was approved by the European Commission as the first and only targeted medicine for children as young as six months old with severe atopic dermatitis
- Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi said “A vast majority of people with atopic dermatitis begin to develop symptoms during their earliest, most vulnerable years, and these symptoms can often continue through the rest of their lives. With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood. Given its well-established safety and efficacy profile, Dupixent has the potential to transform the landscape for people of all ages living with atopic dermatitis. We remain committed to exploring Dupixent for the treatment of other chronic inflammatory skin diseases."
- George D. Yancopoulos, President and CSO at Regeneron said “No infant or child should have to spend their earliest days suffering with the intense and unrelenting itch and skin pain of atopic dermatitis. Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease. In the pivotal trial, Dupixent reduced itch and skin pain and improved health-related quality of life and sleep quality. Dupixent is currently being used to treat more than 600,000 patients around the world across approved indications. This latest EU approval brings the proven efficacy, and importantly, the long-term safety profile of Dupixent to this particularly vulnerable population.”
In Mar 2017, Dupixent was approved by the US FDA as the first targeted biologic therapy for adults with moderate-to-severe atopic dermatitis.
- Olivier Brandicourt, CEO of Sanofi said, "The approval of DUPIXENT offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally."

* Key Opinion Leaders (KOLs) are crucial when it comes to the launch and assessment of pharmaceutical products. At Octavus, we recognize the importance of KOLs in the industry, which is why our proficient team dedicatedly tracks their activities and provides valuable insights to the pharma fraternity.

We understand that KOL tracking and selection can be overwhelming and time-consuming. That's why we offer extensive KOL tracking services to help our clients stay ahead of the curve. Our team of experts can provide you with the latest information on KOL activities, including their opinions, publications, and affiliations.

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