FDA Approves New Dupixent® (dupilumab) 300mg Single-Dose Pre-filled Pen for At-Home Treatment of Type 2 Inflammatory Diseases
Jun 24, 2020 17:26
CST Updated
17:06
Sanofi
Pharmaceutical R&D Developer
Regeneron
Biopharmaceutical Manufacturer
FDA
U.S. Food and Drug Administration
June 24, 2020 News /BioValleyBIOON/ -- Sanofi and Regeneron recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved the 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). This pre-filled pen is approved for all indicated indications in patients aged ≥12 years, including certain cases of atopic dermatitis,AsthmaPatients with chronic rhinosinusitis with nasal polyps (CRSwNP) can receive treatment at home. This new pre-filled injection pen will provide patients with a more convenient treatment option.
Notably, just last week, Dupixent® (dupilumab) received approval from China’s National Medical Products Administration (NMPA) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. As the first and only targeted biologic approved globally for this indication, Dupixent® addresses an unmet clinical need in China by rapidly, significantly, and sustainably improving skin lesions and pruritus in patients with atopic dermatitis. Benefiting from regulatory reforms, Dupixent® was approved in China two years ahead of schedule, providing Chinese patients with a novel therapeutic option.
Dr. George D. Yancopoulos, Co-founder, President, and Chief Scientific Officer of Regeneron, stated, “Chronic type 2 inflammatory diseases, such as atopic dermatitis,”Asthmaand chronic rhinosinusitis with nasal polyps, which are exceptionally complex to manage, causing patients to feel burdened and anxious about their treatment options. Dupixent pre-filled pen is specifically designed to provide patients with an easy-to-use and convenient option, allowing them to administer injectable therapy more comfortably.”
Dupixent 300 mg pre-filled pen is expected to be launched in the United States in the third quarter of 2020. This pre-filled pen features a hidden needle and single-push automatic injection, along with visual and audio feedback to assist with administration. Regeneron and Sanofi are collaborating withFDACollaborate to provide the additional data required for the agency’s review of the 200 mg pre-filled pen. The pre-filled syringe will continue to be marketed in two doses, 200 mg and 300 mg, for use in clinics or for self-administration at home. Both administration methods require training by healthcare professionals.
Bill Sibold, Executive Vice President and Head of Genzyme, a Sanofi company, stated, “We recognize that administering or receiving injections, particularly for medications that patients need to take regularly, can be daunting for patients, their parents, or caregivers. The Dupixent pre-filled pen incorporates the latest technology, including visual and audio cues, to provide support during the administration of this medication.”
Dupixent targets the key drivers of type 2 inflammation. This drug is a fully human monoclonal antibody that 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 launched in late March 2017, becoming the first biologic agent for the treatment of moderate-to-severe atopic dermatitis worldwide. To date, the drug has been approved in multiple countries and regions, including the United States, the European Union, and Japan. In the United States, Dupixent is currently approved for the treatment of three diseases driven by type 2 inflammation: moderate-to-severe atopic dermatitis (in patients aged ≥6 years), moderate-to-severeAsthma(patients aged ≥12 years), chronic rhinosinusitis with nasal polyps (CRSwNP, adult patients).
Currently, Sanofi and Regeneron are also conducting an extensive clinical program to evaluate Dupixent for the treatment of diseases caused by allergies and other type 2 inflammatory conditions, including: childrenAsthma(6–11 years, Phase III), pediatric atopic dermatitis (6 months to 5 years, Phase II/III), eosinophilic esophagitis (Phase III), chronic obstructive pulmonary disease (Phase III), bullous pemphigoid (Phase III), prurigo nodularis (Phase III), chronic spontaneous urticaria (Phase III), and food and environmental allergies (Phase II).
Dupixent is another key product co-developed by Sanofi and Regeneron, following their collaboration on the PCSK9 inhibitor lipid-lowering drug Praluent, and holds promise as a game-changing therapy. Currently, the indications for Dupixent are steadily expanding. EvaluatePharma, a renowned pharmaceutical market research firm, previously projected that the drug’s global sales could reach $8 billion in 2024.(Bio Valley Bioon.com)