Dupixent (dupilumab) Approved by European Commission as First Biologic for Moderate-to-Severe Atopic Dermatitis in Adolescents Aged 12 and Older
Aug 07, 2019 09:56
CST Updated
09:56
Sanofi
Pharmaceutical R&D Developer
Regeneron
Biopharmaceutical Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
August 07, 2019 /BioValleyBIOON/ -- French pharmaceutical giant Sanofi and its partner Regeneron recently announced that the European Commission (EC) has approved the anti-inflammatory drug Dupixent (dupilumab) for adolescent patients (aged 12–17 years) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. Notably, Dupixent is the first biologic agent approved in the EU for the treatment of adolescents with moderate-to-severe AD. Previously, Dupixent had already been approved in the EU for adult patients with moderate-to-severe AD who are candidates for systemic therapy, making it the first biologic agent for the treatment of this adult patient population as well.
In late June this year, Dupixent received U.S.FDAApproval of a new indication: in combination with other medicines, for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is inadequately controlled. This indication was approved via the Priority Review program. Notably, Dupixent is the first biologic therapy approved for the treatment of CRSwNP. In the United States, the drug is now approved to treat three diseases driven by type 2 inflammation: moderate-to-severe AD (≥12 years of age), moderate-to-severeAsthma(≥12 years), CRSwNP (adults).
EC Approves Dupixent for Adolescent Patients with Moderate-to-Severe AD, Based on Clinical Data from the LIBERTY AD Program, Including a Pivotal Phase III Study and an Open-Label Extension Study, Which Evaluated the Efficacy and Safety of Dupixent in Adolescents with Uncontrolled Moderate-to-Severe AD. Results Demonstrated Significant Improvements in Both Primary and Secondary Endpoints with Dupixent Compared to Placebo. The Safety Profile of Dupixent in Adolescent Patients with AD Was Consistent with That Observed in Adult AD Clinical Studies.
Atopic dermatitis is a severe chronic inflammatory skin disease, primarily characterized by intense pruritus, prominent eczematous changes, and xerosis. The disease often onset in infancy and childhood, with some patients affected throughout their lifetime. It can significantly impair patients' quality of life due to chronic relapsing eczematous rashes, severe pruritus, sleep deprivation, dietary restrictions, and psychosocial impacts.
Dupixent targets the key drivers of type 2 inflammation. This fully human monoclonal antibody specifically inhibits the overactivated signaling of two key proteins, IL-4 and IL-13. IL-4 and IL-13 are two inflammatory cytokines considered to be the key drivers of intrinsic inflammation in allergic diseases and other type 2 inflammatory conditions, including atopic dermatitis,Asthma, eosinophilic esophagitis, grass allergy, peanut allergy, etc.
Dupixent was approved in late March 2017, becoming the first biologic agent worldwide for the treatment of moderate-to-severe atopic dermatitis (AD), and subsequently received approvals for indications in moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Currently, Sanofi and Regeneron are conducting an extensive clinical program to evaluate Dupixent for the treatment of diseases driven by allergic and other type 2 inflammatory responses, including: pediatricAsthmaand atopic dermatitis (ages 6–11, Phase III), pediatric atopic dermatitis (6 months to 5 years, Phase II/III), eosinophilic esophagitis (Phase II/III), chronic obstructive pulmonary disease (Phase III), and food and environmental allergies (Phase II). In addition, the two parties plan to conduct a clinical study to evaluate the combination therapy of Dupixent with REGN3500, an IL-33-targeting monoclonal antibody.
Dupixent is another key product co-developed by Sanofi and Regeneron, following their collaboration on the PCSK9 inhibitor lipid-lowering drug Praluent. In 2018, global sales of Dupixent reached $788 million. Recently, Sanofi released its financial results for the first half of 2019. As of June 30, global sales of Dupixent in the first half of the year amounted to €825 million, with U.S. market sales reaching €669 million, representing year-on-year increases of 1.9-fold and 1.5-fold, respectively, compared to the same period last year (€283 million and €246 million, respectively). In the report, Sanofi also projected thatAsthmaThe commercial launch in this area and strong penetration in atopic dermatitis (AD) will further boost Dupixent sales, which are projected to reach €2 billion in 2019.
EvaluatePharma, a pharmaceutical market research firm, predicts thatLooking ahead, with the steady increase in indications and the continuous expansion of the treated population, Dupixent will become a key product driving Sanofi’s future growth, with global sales potentially exceeding $5 billion in 2024. (Bioon.com)