Author Interviews, Dermatology, FDA, Regeneron, Sanofi / 31.07.2020

MedicalResearch.com Interview with: Elizabeth Laws, PhD Vice President and Global Project Head for Dupilumab/Dupixent Sanofi Marcie Ruddy, MD, MA Strategic Program Direction, Immunology and Inflammation Regeneron  Dr. Laws and Dr. Ruddy discuss the FDA approval of a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab) for all indications in patients aged 12 years and older.   MedicalResearch.com: What is the background for this announcement? What are the main indications for Dupixent? Response: Until now, Dupixent 300 mg dose was available only in pre-filled syringe for administration. The approval of the pre-filled pen provides an additional, easy-to-use option for patients to self-administer Dupixent. Dupixent is approved to treat patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis (AD) and can be used with or without topical treatments. Dupixent is also approved for use with other medicines for the maintenance treatment of uncontrolled moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older, and with other medicines for the maintenance treatment of uncontrolled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, respectively. The pre-filled pen is approved for use in patients prescribed Dupixent who are 12 years of age and older across current indications, at the 300 mg dose. (more…)
Author Interviews, Dermatology, Regeneron / 23.06.2020

MedicalResearch.com Interview with: Brad Shumel, MD Senior Director of Medical Affairs, Immunology Regeneron MedicalResearch.com: What is the background for this study? Response: Atopic dermatitis is a chronic inflammatory disease and one of the most common skin disorders in children. Severe atopic dermatitis is characterized by skin lesions that often cover a large body surface area and can include intense, persistent itch. Uncontrolled moderate-to-severe atopic dermatitis can have a physical, emotional and psychosocial impact on children, resulting in sleep deprivation, activity restriction, poor school performance, depression and anxiety that can have a greater impact on quality-of-life. The standard of care for this pediatric population has been topical corticosteroids. Children with severe atopic dermatitis who remain uncontrolled with topical therapies have limited treatment options. This Phase 3 trial was conducted to evaluate the safety and efficacy of dupilumab plus topical corticosteroids (TCS) compared with TCS alone in children with uncontrolled severe atopic dermatitis across two treatment arms – every four weeks and every two weeks (Q4W and Q2W). (more…)
Author Interviews, Dermatology, Pediatrics, Pharmaceutical Companies, Regeneron / 15.06.2020

MedicalResearch.com Interview with: Amy S Paller, MD Chair, Department of Dermatology Director, Skin Biology and Diseases Resource-Based Center Walter J. Hamlin Professor of Dermatology Professor of Dermatology and Pediatrics (Dermatology) Feinberg School of Medicine Northwestern University  Dr. Paller discusses the FDA approval of Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (eczema), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.  MedicalResearch.com: What is the background for this announcement? Would you briefly discuss what is meant by atopic dermatitis and how it affects children? Response: “Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. This recent FDA approval expands the use of Dupilumab in the U.S. to include children aged 6 to 11 years with uncontrolled moderate-to-severe atopic dermatitis, making it the only biologic medicine approved for this use in this population. Dupilumab is also approved in the U.S. to treat patients aged 12 years and older with moderate-to-severe atopic dermatitis. Moderate-to-severe atopic dermatitis can place a particularly substantial burden on young children aged 6 to 11 years and their families. Limited treatment options leave many of these children to cope with intense, unrelenting itch and skin lesions. Families of these children can spend countless hours helping them to manage their disease.” (more…)
Author Interviews, Diabetes, Ophthalmology, Regeneron / 17.05.2019

MedicalResearch.com Interview with: Robert L. Vitti, MD, MBA Vice President and Head, Ophthalmology Regeneron Pharmaceuticals Dr. Vitti discusses the recent announcement that the FDA has approved EYLEA to treat all stages of diabetic retinopathy. MedicalResearch.com: Can you provide additional background on this approval? Would you briefly explain diabetic retinopathy and it's impact on patients? Response: The FDA has approved EYLEA (aflibercept) Injection to treat all stages of diabetic retinopathy (DR). DR is the leading cause of blindness among working-aged American adults. Approximately 8 million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina (per 2010 data). The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. (more…)
Asthma, Author Interviews, FDA, Regeneron / 31.10.2018

MedicalResearch.com Interview with: RegeneronNeil Graham,  M.B.B.S., M.D., M.P.H VP of Immunology & Inflammation Regeneron MedicalResearch.com: What is the background for this announcement?  Response: Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. [i],[ii] Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects. [iii],[iv] A particular type of inflammation contributes to the cause of uncontrolled symptoms in multiple inflammatory diseases such as asthma and atopic dermatitis.[v] Dupixent is a medicine that inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to this type of inflammation. This inhibits cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE; however, the mechanism of action of Dupixent in asthma has not been definitively established. (more…)