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, Nature / 22.11.2019

MedicalResearch.com Interview with: Dr. Gary J. Nabel M.D., Ph.D. Chief Scientific Officer, Global Research and Development Sanofi MedicalResearch.com: What is the background for this study? Response: The power of T cell co-stimulation in the immune system became apparent to the immunology community from basic studies on T cell activation and T cell receptor function dating back to the 1980’s and 1990’s.  As a professor at the University of Michigan and investigator at its Howard Hughes Medical Institute in the 1990’s, I became aware of this pathway through collaborations with Carl June and Craig Thompson in the 1990s.  When we stimulated T cells by engaging CD3 (a T cell receptor activation signal e.g. signal 1) and CD28 (a survival signal e.g. signal 2), we found that the co-stimulatory effect led to exceptional T cell proliferation. After our Sanofi team developed the trispecific antibody technology, we realized that it might be possible to engage CD3 and CD28 while targeting T cells to tumors with a third arm, CD38, which is highly expressed on myelomas, all interactions mediated by this one protein.  (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…)