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, Heart Disease, Lipids, Sanofi / 29.11.2017

MedicalResearch.com Interview with: Dr. Jay Edelberg MD, PhD VP Head of CV Development and Head Global CV Medical Affairs Sanofi  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with heterozygous familial hypercholesterolemia (HeFH) are often not able to achieve their target low-density lipoprotein cholesterol (LDL-C) levels, and some may require lipoprotein apheresis (LA) to lower their “bad cholesterol.” Apheresis is a procedure similar to kidney dialysis, where bad cholesterol is mechanically removed from the blood. It is an invasive, expensive, and time-consuming treatment for patients, as well as physicians. The Phase III ESCAPE clinical study looked at the potential effect of LA on total Praluent, free and total PCSK9 concentrations, as well as the combined pharmacodynamics effect of total Praluent on LDL-C-lowering. Praluent levels remained unaffected by apheresis, and Praluent consistently suppressed free PCSK9 levels in patients with HeFH, regardless of LA treatment. This analysis further confirms clinical ESCAPE data that Praluent can be used in conjunction with LA and may reduce or potentially eliminate the need for LA in some patients. (more…)
Author Interviews, Lipids, Sanofi / 29.11.2017

MedicalResearch.com Interview with: Dr. Jay Edelberg MD, PhD VP Head of CV Development and Head Global CV Medical Affairs Sanofi MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clinical trials of lipid-lowering therapies (LLTs), including statins, often report variations in treatment response regarding effects on low density-lipoprotein cholesterol (LDL-C) levels, although LDL-C reductions are fairly consistent between trials. Praluent is generally well tolerated, however hyporesponsiveness exists in few patients. Potential causes for variation in patient responsiveness to Praluent include lack of receipt of active study drug, changes in concurrent LLTs, inaccurate or unrepresentative baseline lipid levels, concurrent acute-phase illness, and biological nonresponsiveness. This analysis evaluated patients pooled from 10 ODYSSEY trials to assess characteristics of patients with hyporesponsiveness to Praluent, defined as <15% LDL-C reduction from baseline at all analyzed time points. Overall, only 1% of patients (n=33) had <15% LDL-C reduction at all time points. Prolonged hyporesponsiveness to Praluent was rarely associated with Praluent antidrug antibodies. Of the 33 patients with <15% LDL-C reduction at all study timepoints, 27 had undetectable or missing alirocumab levels, absence of pharmacokinetics analyses, or early treatment discontinuation. (more…)