European Commission approves Dupixent to treat Atopic Dermatitis in Children

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November 30, 2020 – The European Commission (EC) has extended the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent (often known as eczema) is the only systemic medicine approved in the EU to treat these patients.

“As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I’ve seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family,” said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER).

European Commission approves Dupixent to treat Atopic Dermatitis in Children

“Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients.”

Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families.

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The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, leaving those with the poorly controlled disease to cope with intense, unrelenting itch and skin lesions that can cover much of the body, resulting in skin cracking, redness or darkening, crusting and oozing. In addition, uncontrolled severe atopic dermatitis can have a substantial emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression and feelings of isolation in children.

 “The approval of Dupixent for children in Europe marks another significant milestone for atopic dermatitis patients and their families, broadening the availability of a first-in-class medicine that offers a proven safe and effective treatment for this debilitating skin disease,” said John Reed, M.D., PhD, Global Head of Research and Development at Sanofi.

“Dupixent’s ability to provide significantly clearer skin, and clinically meaningful reduction of persistent itch, address important unmet needs for these children. In addition to atopic dermatitis, we continue to investigate the potential of Dupixent in younger age groups and across a variety of type 2 inflammatory diseases.” 

Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

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“This approval for Dupixent in the EU represents a major advancement for children with severe atopic dermatitis and their families, who spend countless days and nights tending to their child’s disease with few treatment options to help alleviate the debilitating symptoms,” said George D. Yancopoulos, M.D., PhD, President and Chief Scientific Officer at Regeneron.

“Dupixent is a novel therapy that addresses a root cause of atopic dermatitis by specifically targeting the underlying type 2 inflammation of the disease. Dupixent has already been used by hundreds of thousands of patients around the world, including those with atopic dermatitis as well as other type 2 inflammatory diseases such as asthma and adults with chronic rhinosinusitis with nasal polyps.  We are pleased to bring this paradigm-changing medicine to even younger patients in the EU who need new options beyond steroids or immunosuppressants.” 

In children aged 6-11 years weighing 15 to <60 kg, Dupixent 300 mg is administered as an injection under the skin (subcutaneous injection) every four weeks following the initial loading dose given as two injections 14 days apart. For those weighing >60 kg, Dupixent 300 mg is administered every two weeks following the initial loading dose given the same day. The dose may be increased to 200 mg every two weeks in patients weighing 15 to <60 kg based on the physician’s assessment.

Pivotal trial data

The EC decision is based primarily on data that includes pivotal Phase 3 efficacy and safety results of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone (placebo) in children 6-11 years with severe atopic dermatitis. At 16 weeks, patients in treatment groups of Dupixent 300 mg every four weeks (N=122) or 200 mg every two weeks (N=59) with TCS experienced:

  • Improved disease extent and severity: 82% and 80% average improvement from baseline with Dupixent every four and two weeks, respectively, compared to 49% and 48% for placebo. In addition, 70% and 75% of Dupixent patients achieved at least a 75% improvement in the four-week and two-week treatment groups, respectively, compared to 17% and 26% for placebo.
  • Skin clearance: 33% and 39% of patients achieved clear or almost clear skin with Dupixent every four and two weeks respectively, compared to 11% and 10% for placebo.
  • Reduced itch: 51% and 61% of patients achieved clinically significant reduction with Dupixent every four and two weeks, respectively, compared to 12% and 13% for placebo. A significantly greater proportion of Dupixent patients achieved improvement in itch as early as four weeks.
  • Improved health-related quality of life (HR-QoL): 77% and 81% of patients experienced clinically meaningful improvement in patient-reported HR-QoLwith Dupixent every four and two weeks, respectively, compared to 39% and 36% for placebo. Dupixent patients also experienced improvements in additional HR-QoL measures assessing disease severity and patient-reported measures such as itch and sleep.
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The safety profile of Dupixent in children 6-11 years of age followed through week 52, based on an open-label extension trial, was similar to the safety profile observed at week 16 and consistent with the safety profile seen in adults and adolescents with atopic dermatitis. Overall rates of adverse events (AEs) were 65% and 61% for Dupixent every four and two weeks respectively, and 73% and 75% for placebo.

AEs that were more commonly observed with Dupixent included upper respiratory tract infections (11% and 9% for Dupixent every four and two weeks, 10% and 12% for placebo), injection site reactions (10% and 14% for Dupixent every four and two weeks, 6% and 5% for placebo), nasopharyngitis (13% and 3% for Dupixent every four and two weeks, 7% and 10% for placebo), conjunctivitis (7% and 9% for Dupixent every four and two weeks, 4% and 5% for placebo), and fever (3% for both Dupixent groups, 2% and 0% for placebo).

Additional prespecified AEs included skin infections (6% and 9% for Dupixent every four and two weeks, 13% for both placebo groups), and herpes viral infections (2% for both Dupixent groups, 5% for both placebo groups).

The co-primary endpoints in the pediatric trial were skin clearance, as measured by a score of 0 or 1 on the Investigator’s Global Assessment (IGA), and disease extent and severity, as measured by Eczema Area and Severity Index score (EASI-75).

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Secondary endpoints included the average change in EASI score from baseline, and itch as measured by at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale). Additionally, HR-QoL was measured by the proportion of patients who achieved at least six points on the patient-reported Children’s Dermatology Life Quality Index (CDLQI), as well as additional measures from Patient-Oriented Eczema Measure (POEM) and SCORing Atopic Dermatitis (SCORAD).

Dupixent is approved for specific patients with atopic dermatitis, asthma and/or in adults with CRSwNP in a number of countries around the world, including the European Union, U.S. and Japan. Dupixent is currently approved in more than 60 countries, and more than 200,000 patients have been treated globally.

Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver. No initial lab testing or ongoing lab monitoring is required with Dupixent treatment in any approved indication or age group.

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European Commission approves Dupixent to treat Atopic Dermatitis in Children - Brand SpurEuropean Commission approves Dupixent to treat Atopic Dermatitis in Children - Brand Spur

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European Commission approves Dupixent to treat Atopic Dermatitis in Children - Brand SpurEuropean Commission approves Dupixent to treat Atopic Dermatitis in Children - Brand Spur

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Accelerates Expansion into Global Market

 

HONG KONG SAR - Media OutReach - 28 January 2021 - China Dynamics (Holdings) Limited (the "Company"; Stock Code: 476, together with its subsidiaries, collectively "China Dynamics" or the "Group"), a provider of new energy vehicles and technology integrated solutions, has announced its Team of International Advisors for supporting its growth strategy in the global market.

 

The Team of International Advisors comprises Mr. Michael Perschke, Ms. Monika Mikac and Mr. Matthew Green.

 

Mr. Michael Perschke, Founder & Former CEO of Automobili Pininfarina, is the CEO of NAD (New Automovile Development). He has been in the automotive industry for 25 years, having served at such companies as Daimler Group, Mitsubishi Motors and Volkswagen Group, including the CEO of AUDI India. In respect of Mitsubishi Motors, he played a major role in the company's turnaround in Europe, whereas at AUDI, he demonstrated his strong branding background by creating the "AUDI SPORT" brand by uniting all Audi S and RS models under an umbrella brand strategy. In addition, Mr. Perschke ventured into the electric vehicle ("EV") segment and successfully developed the brand and sales strategy for the EV brand of AUDI -- the eTron. In early 2018 he founded Automobili Pininfarina as the first fully sustainable luxury EV brand, capitalizing on the legendary Italian design company Pininfarina, and supported by his key investor, the Mahindra Group (India). Mr. Perschke is among the top 20 global EV leaders and recently joined NAD -- an investment firm focusing on investments in EV, autonomous and connected technologies.

 

Mr. Perschke will support China Dynamics' European and Latin America market expansion and make contributions to the Group's investment and funding activities by leveraging his personal network.


Included among the European Automotive Rising Stars, Ms. Monika Mikac started her career as COO of Rimac Automobili; helping the company grow from a handful of employees to around 350 people. In being one of its first five staff members meant that she had to engage in a diverse scope of activities, spanning public relations and marketing to finance and administration. She also actively participated in fundraising efforts and helped Rimac Automobili to close their first round of funding in 2014 for €10 million, which was followed by €30 million in 2017.

 

With her extensive experience in marketing and business development, Ms. Mikac will be entrusted with helping support China Dynamics on its path towards becoming an internationally renowned electric bus manufacturer.

 

Mr. Matthew Green has been active as a principal and advisor in several transactions across diversified alternative asset classes, including renewable energy, real estate, technology and infrastructure, and covering key western European markets and large-scale emerging markets. With a focus on capital raising, transaction origination and debt financing, he has concluded transactions or advised on financing activities with leading global organizations, including Blackstone, Cerberus, BAML, GI Partners, and Bank of China Asset Management.

 

Mr. Green will assist in the Company's growth in the capital market by fostering new relations with leading global investors and forging industry alliances.

 

Mr. Miguel Valldecabres Polop, CEO of China Dynamics, said, "We are delighted and will look forward to working with the new team of professional advisors. As China Dynamics is growing into a leading global EV bus player and last mile transportation leader, it is critical that we build a diverse and globally experienced team to help the Company fulfill its mission of becoming one of the foremost international players in the market. The advisors are expected to draw on their wealth of knowledge and experience in the international marketplace to help China Dynamics identify opportunities around the world, accelerate its growth and strengthen its global presence."

About China Dynamics (Holdings) Limited (Stock Code: 476)

China Dynamics (Holdings) Limited is a pioneer and a prominent player in China's new energy commercial vehicles market, as well as a whole-vehicle manufacturer of specialty passenger vehicles and new energy passenger vehicles. It is an integrated driving and logistics solutions provider with a solid technological foundation in diverse areas including new energy platform power system and its key components. The Group has two production bases in Chongqing and it has developed its sales network in Mainland China, Hong Kong and the Philippines.

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