Sanofi and pCPA Sign Letter of Intent for Dupixent® Across Four Indications in Dermatology and Respiratory Care

Sanofi to work with provinces, territories, and federal drug programs to support patient access through public drug plans

Sanofi today announced the successful completion of negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA) and Sanofi with a signed Letter of Intent (LOI) for Dupixent for four additional indications: atopic dermatitis (AD) in pediatric patients, prurigo nodularis (PN), severe chronic rhinosinusitis with nasal polyposis (CRSwNP), and chronic obstructive pulmonary disease (COPD). Sanofi looks forward to working with public payers to support access for eligible patients.

"This agreement with the pCPA is an important step forward in expanding patient access to the first advanced biologic therapy approved for pediatric atopic dermatitis, prurigo nodularis, chronic rhinosinusitis with nasal polyposis, and COPD," said James Guy, General Manager, Specialty Care and Country Lead, Sanofi Canada.

Addressing Unmet Patient Need in Type 2 Inflammatory Diseases

Dermatology Indications in Atopic Dermatitis and Prurigo Nodularis  

Dupixent is indicated for patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.¹ Atopic dermatitis is the most common form of eczema — estimated to affect 15% of children and 4% of adults in Canada. ^2,3 Dupixent is also indicated for adult patients with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies.¹ Prurigo nodularis is a chronic neuroimmune-mediated skin disease characterized by intensely pruritic nodules and plaques. ⁴ 

"I see firsthand the physical and emotional burden that unmanaged atopic dermatitis has on pediatric patients and their families, as well as adults living with prurigo nodularis," said Dr. Chih-ho Hong, MD, FRCPC, Board-Certified Dermatologist in British Columbia. "This news represents a meaningful step in addressing unmet needs and advancing care."

"For children living with moderate-to-severe atopic dermatitis and their families, the physical and emotional toll can be overwhelming. Similarly, for people living with prurigo nodularis, persistent symptoms can significantly affect sleep, mental health, and social life. This milestone in the reimbursement process is encouraging for patients and their families who are seeking additional treatment options," said Amanda Cresswell-Melville, Executive Director of Eczema Society of Canada (ESC).

Respiratory Indications in COPD and CRSwNP 

Dupixent is indicated for the treatment in adult patients with COPD characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.¹ More than two million Canadians live with this progressive lung disease, which is the fifth leading cause of death in Canada. ^5,6

"COPD is a growing public health challenge affecting about 9% of Canadians aged 35 and older. This agreement represents critical progress that could help more Canadians access a therapy that targets the underlying biology of their disease," said Dr. Ken Chapman, MD, FRCPC, Respirologist in Ontario.

"Many Canadians living with COPD experience disruptive exacerbations and breathlessness, which can have a significant impact on their daily lives and overall quality of life. This letter of intent represents a meaningful step forward, offering hope to Canadians living with uncontrolled COPD who may benefit from an additional treatment option," said Henry Roberts, Managing Director, COPD Canada.

Dupixent is also indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe CRSwNP inadequately controlled by systemic corticosteroids and/or surgery.¹ Severe CRSwNP is defined by persistent symptoms including nasal obstruction, facial pain, nasal discharge, and decreased sense of smell. ⁷

"Severe chronic rhinosinusitis with nasal polyposis can cause debilitating symptoms that profoundly impact patients' quality of life. Access to targeted therapies like Dupixent would be welcome news for patients seeking more treatment options," said Dr. Martin Desrosiers, MD, Rhinologist in Quebec. 

"This agreement marks a major step forward for patients managing severe chronic rhinosinusitis with nasal polyposis and their families," said Jeffrey Beach, President and CEO, Asthma Canada.

About Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. 

In Canada, Dupixent has received authorization for sale for eligible patients across atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and COPD, across different age populations.¹ More than 1,500,000 patients globally are being treated with Dupixent, including more than 45,000 patients in Canada.

Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation.

For more information about Dupixent (dupilumab), please refer to the Canadian Product Monograph. 

About Sanofi 

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.

Sanofi is the largest biopharma manufacturer in Canada, and is investing, innovating and operating across the full life sciences value chain. We are 2,000+ employees strong, invest 20% of our revenue annually in biopharma research, and are on track to deliver over $2 billion in new infrastructure investments by 2028. We also recently announced a $294 million investment to expand our AI Centre of Excellence in Toronto, enabling us to accelerate innovation for patients. Sanofi is committed to our community and is working with partners to foster a long-term sustainable ecosystem and build a healthier Canada.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. 

References

SOURCE Sanofi

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