Sanofi Announces Availability of Dupixent® (dupilumab) for Adults with Moderate-to-Severe Atopic Dermatitis in Malaysia

Sanofi announced that the Ministry of Health has granted market approval for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Atopic dermatitis (AD), one of the most prevalent form of eczema, is a chronic inflammatory disease with symptoms of recurrent red itchy rashes on the skin.3-6 Caused, in part, by an underlying inflammation in the body that is believed to be driven by an overactive immune system,5 AD is a complex, systemic disease that has significant physical and psychological impact.7,8 Moderate-to-severe atopic dermatitis is characterized by widespread rashes associated with intense, persistent itching, skin dryness, redness, cracking, crusting, and oozing.9,10 People with inadequately controlled moderate-to-severe AD experience debilitating symptoms despite using available treatment options.

Elaine, in her mid-30s, (real name changed to conceal identity) is not alone, as 1 in 5 Malaysians suffer from AD1. She has been living with moderate-to-severe AD since she was a teenager. What started out as a single rash spot, gradually manifested into painful and intense itching areas over her entire body. Elaine was diagnosed with moderate-to-severe AD, and over the years has tried both medical and alternative treatment options, with many failing to improve her condition while others only offered temporary relief. Because of her condition, Elaine could not indulge in the activities she loved, like swimming and Zumba because both sweat and chlorine in swimming pool water would aggravate her condition and result in further skin rashes, cracks, flaking and bleeding. Elaine reluctantly learnt to avoid these activities, together with other triggers like certain weather conditions including direct sunlight and rain.

“Many Malaysians’ adults suffer from AD, and every day can be a challenge for people living with AD. Especially when you add lifestyle misconceptions and poor treatment adherence to the mix, the challenge is further magnified because you now have a situation where patients are suffering with atopic dermatitis, with their current treatment not addressing their condition. When this persists, you’ll start to see a negative impact on quality of life because AD attacks on both a physical and psychological level. The multidimensional burden of atopic dermatitis can be pervasive throughout patients’ lives, trapping patients in a continuous cycle of disease and distress,” said Dr. Bong Jan Ling, Consultant Dermatologist, Sunway Medical Centre.
According to the Dermatological Society of Malaysia, only 14.7% of AD patients were adherent to treatment, while 58.7% of patients had steroid phobia, which posed a problem. Dato' Dr. Noor Zalmy Azizan, Vice President of the Dermatological Society of Malaysia explains, “Topical corticosteroid is one of the most commonly used treatment modalities in AD patients. It’s commonly prescribed because of its potent anti-inflammatory and antiproliferative effects. However, without proper adherence, people with moderate-to-severe atopic dermatitis that is inadequately controlled experience impaired quality of life, including disrupted sleep, increased anxiety and depression symptoms along with their disease11.”

A biologic therapy that targets the root cause of AD inflammation

Unmet needs of AD patients are significant, with patients reported to feel that the disease negatively impacts various aspects of their life, influencing important life decisions, both socially and professionally. During an exacerbation, people with AD reported that 10% of their working time is affected12.
“The combination of poor treatment adherence and the lack of novel treatment options play significant roles in the under-treatment of AD in Malaysia. Thankfully today, we have a breakthrough with a biologic therapy that addresses the root cause of inflammation. The need for a breakthrough treatment like this is a game-changer for people living with moderate-to-severe AD. The availability of this treatment that is both not a steroid and conventional immunosuppressant offers another option patients can consider, as having timely access to treatment options is critical to help them provide relief for this life-altering chronic disease,” Dr. Bong elaborates.

Dupixent is a human monoclonal antibody that is designed to inhibit overactive signalling of two key proteins, IL-4 and IL-13, by blocking a receptor common to the two proteins. IL-4 and IL-13 are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis, and certain other allergic or atopic diseases13,14. Dupixent will come in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.14

Due to its innovative mechanism of action (MOA) inhibiting one mechanism associated with the underlying persistent inflammation, Dupixent addresses the significant unmet needs by demonstrating consistent, rapid and sustained long-term efficacy on signs and symptoms of atopic dermatitis, and enabling Quality of Life, when used concomitantly with topical therapy or as a monotherapy.The use of Dupixent has shown significant skin improvement and itch reduction in 16 weeks among patients participated in clinical trials.*

“The approval of Dupixent in Malaysia demonstrates Sanofi’s approach in bringing innovative treatments to patients living with moderate-to-severe atopic dermatitis in Malaysia,” said Dr Shiva Patil, Medical Head of Sanofi Malaysia, Singapore & Thailand, “As a healthcare journey partner, we are committed to transform scientific ideas to therapeutic solutions in unmet needs of people suffering from debilitating diseases. In this journey, Dupixent® is a biologic therapy that is recently approved by the Malaysia’s Health Ministry to treat the underlying cause of moderate-to-severe atopic dermatitis in adult patients. Dupixent helps significant number of patients to regain control of their lives by reducing bothersome signs and symptoms of AD. We are now focused on making this new treatment option available to people across Asia”.

Dupixent was first launched in the US and European Union in 2017, and was approved in Malaysia in May 2019 for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. The U.S. and EC approval of Dupixent was based on data from the global LIBERTY AD clinical trial program* which included approximately 3,000 adults living with this serious disease15,16,17.

Dupixent is being developed jointly by Regeneron and Sanofi as part of a global collaboration agreement.

About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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