Sanofi's Dupixent (ingredient: dupilumab), the only biologic drug for atopic dermatitis, has finally won the local health insurance coverage for patients with serious atopic dermatitis this year.

The government recently designated Dupixent as the first medicine to apply an extended risk-sharing agreement (RSA), as social demand for the new drug was high. The government had applied RSA only to the treatments of severe and rare diseases until then.

In negotiations with Sanofi, the government proposed three types.

They are: “Initial refund type” that the drugmaker refund all costs for the initial-stage dose; “refund type” that the company reimburses a certain proportion of the drug expenses to the National Health Insurance Service throughout its use: and the “total amount limit type” that the government limits the total amount of reimbursement to secure the NHIS’ fiscal soundness.

Sanofi agreed to the proposal and finally obtained insurance coverage for Dupixent in 16 months after the market release of the drug.

Korea Biomedical Review recently met with Brian Foard, global lead in dermatology and respiratory at Sanofi Genzyme, who visited Korea to celebrate the domestic reimbursement for Dupixent.

Foard shared Dupixent’s performance and Sanofi Genzyme’s development plans.

Sanofi Genzyme’s immunology division focuses on the research and development of pipelines targeting immune system disorders. Flagship treatments include Dupixent and REGN3500, an interleukin 33 (IL-33) targeting monoclonal antibody.

Dupixent received approval for dermatology and respiratory diseases and is under review for obtaining indications for other type-2 inflammatory disorders. The company is also working to win REGN3500’s indications for various diseases.

Brian Foard, global lead in dermatology and respiratory at Sanofi Genzyme, speaks during an interview with Korea Biomedical Review.

Question: What is the purpose of your visit to Korea?

Answer: Korea is one of the important markets for Sanofi. The significance of the market is not decided only by size and sales. Since entering Korea, Sanofi has dedicated to Korean patients for more than 50 years. Considering the dedication and hard work, Korea is an essential market for Sanofi. This year, in particular, Dupixent obtained reimbursement, so I was happy to visit Korea.

Q: Can you tell us more about Dupixent?

A: Dupixent has won approval for atopic dermatitis in adults in more than 50 countries. In Europe, the U.S., and Canada, it also received the nod as atopic dermatitis drug for adolescents. Around the world, about 125,000 patients are getting Dupixent treatment.

Since Dupixent’s arrival, physicians around the world are changing the approach to atopic dermatitis treatment fundamentally. In the past, treatments were mostly dependent on immunomodulators, oral steroids, and topical steroids. But no drug could fundamentally improve various symptoms. I think Dupixent brought a revolutionary change in patients with atopic dermatitis who have suffered from painful symptoms.

Q: Can you tell us objective data that shows Dupixent’s therapeutic effects?

A: It is difficult to compare before and after the release of Dupixent. Before, treatments for atopic dermatitis did not go through clinical trials that used objective indicators. For example, cyclosporine, a representative systemic immunomodulator, has not been approved as a treatment of atopic dermatitis in many markets. It is the same with methotrexate. Alternative therapies in the absence of fundamental treatments were not directly assessed by objective indicators such as the Eczema Area and Severity Index (EASI), the Itch Numeric Rating Scale (Itch NRS), or Investigator Global Assessment (IGA). So, it is difficult to compare their efficacy with that of Dupixent.

According to the SOLO trial that confirmed Dupixent’s therapeutic effect and safety as a monotherapy, half of the treatment group showed the improvement of more than 75 percent in legion’s size and severity at week 16.

In the CHRONOS study, about two-thirds of patients treated with Dupixent and topical corticosteroids (TCS) showed more than 75 percent improvement in legion’s size and severity at week 52. Also, one in two patients demonstrated a clinically meaningful improvement in itching. At week 16, 38.7 percent of Dupixent-treated patients reached zero or 1 in the IGA score, versus 12.4 percent of the placebo group.

In the CAFE trial on patients not responding to cyclosporine sufficiently or those who cannot use it for medical reasons, Dupixent proved that it was clinically effective in EASI 75, NRS, and Dermatology Life Quality Index (DLQI), compared to placebo.

Q: Dupixent remains the sole biologic drug authorized for the treatment of atopic dermatitis. Why is the development of atopic dermatitis treatment so slow?

A: Type-2 inflammatory diseases, including atopic dermatitis, are relatively less known to the public. Researchers have already found pathogenesis of type-1 inflammatory diseases such as psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn's disease. So they are actively developing many more therapeutic agents based on their pathogenesis studies.

Researchers are still checking the mechanism of how type-2 inflammatory diseases develop and just starting R&D. However, studies on type-2 inflammatory diseases are progressing is a lot speedier than those on psoriasis in the past because scholars already know that IL-4 and IL-13 are significant cytokines in atopic dermatitis or type-2 inflammatory diseases.

Q: What is Sanofi’s plan on Dupixent for further study?

A: Dupixent can be used only for patients aged 12 or older currently. So, we are conducting a trial on younger patients aged over six months. Some patients who develop atopic dermatitis at a young age can suffer from the illness for the rest of their lives, which can seriously impact their quality of life. Thus, I hope Dupixent can be used even in young atopic dermatitis patients. We are working to obtain data that demonstrate the drug’s safety and efficacy in pediatric patients. Once we do so, we will work with regulatory institutions to ensure that as many pediatric patients as possible can receive effective treatment with Dupixent.

Dupixent is also expanding its indication from atopic dermatitis to asthma to chronic sinusitis with nasal polyps. The most critical factors determining the R&D direction, are the unmet needs of patients and scientific research data. As more type-2 inflammatory diseases are being uncovered in additional studies, we will determine our development goals depending on the outcomes of such studies.

Q: Do you have further comments for Korean atopic dermatitis patients and physicians?

A: Atopic dermatitis is one of the diseases that lack a sufficient development of evaluation indexes. Although there are measures to assess seriously ill patients, they are not yet able to adequately represent the problems or pain they are experiencing. Therefore, there is a need for continuous research on the indicators that can accurately assess the severity of the disease as well as patients’ pain.

I would like to ask not only Korean but all health authorities around the world to listen more to the voices of patients. By making a game-changing shift in treatment, we look forward to seeing more patients gain access to innovative therapies that can make a difference in their lives.

kym@docdocdoc.co.kr

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