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Sanofi shines in diabetes and dermatology
October 2016
by Jeffrey Bouley  |  Email the author
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PARIS—In mid-September, Sanofi announced that adults with type 2 diabetes treated with Toujeo (insulin glargine 300 units/mL) experienced a consistently lower rate of confirmed or severe hypoglycemia both at night and at any time of the day compared with those treated with Lantus (insulin glargine 100 units/mL), at all levels of HbA1c (average blood glucose over the previous three months) achieved at month six.
 
These results come out of a new patient-level meta-analysis from the EDITION 1, 2 and 3 Phase 3 clinical trials in patients with type 2 diabetes, and were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany.
 
“For people with diabetes, it is vital to achieve good glycemic control in order to minimize the risk of microvascular complications. Risk of hypoglycemia can be an important factor in the person as well as their treating physician’s attitude towards treatment of their diabetes, and can lead to improved adherence and reduced glycemic control in real-world conditions,” said Pratik Choudhary, senior lecturer and consultant in diabetes at Kings College London and lead author of the presentation. “These results show that in more than 2,000 patients that Toujeo could enable adults with type 2 diabetes to achieve equivalent glycemic control with less hypoglycemia vs. Lantus. We look forward to the validation of these important findings in real-world settings.”
 
And Sanofi does already have some “real-world” evidence, reporting that the first such clinical evidence shows the possibility “in a real-life setting to reflect the possibility of achieving glycemic control with fewer hypoglycemic events.” The evidence, which was presented at the American Diabetes Association’s 76th Scientific Sessions, was drawn from existing patient-level information (from the Predictive Health Intelligence Environment database) on patients switching to Toujeo from other basal insulins under real-life conditions. The results reportedly demonstrated that patients treated with Toujeo experienced a mean estimated reduction in HbA1c of 0.64 percent after six months of treatment, while the occurrence of hypoglycemia was 6 percent at baseline and 5.1 percent at follow-up.
 
“These encouraging meta-analysis findings, in combination with preliminary patient-level data from a real-life setting, provide useful information about Toujeo’s potential to help people with diabetes achieve better glycemic control without additional risk of hypoglycemia,” said Riccardo Perfetti, head of Sanofi’s Global Diabetes Medical Team. “We are currently conducting a broad real-world clinical program to confirm these findings.”
 
Sanofi is conducting three large, randomized clinical trials—ACHIEVE, REACH and REGAIN CONTROL—evaluating in real-life conditions the effect of Toujeo in people with type 2 diabetes.
 
Sanofi followed up that diabetes news with word at the beginning of October that Phase 3 atopic dermatitis data regarding Dupixent (dupilumab) recently published in the New England Journal of Medicine (NEJM) were positive. If and when approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
 
The results arise from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating investigational Dupixent in adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The studies met their primary endpoints evaluating the extent and severity of the disease. In addition, both trials met key secondary endpoints measuring reduction in itch, improvement in patient-reported anxiety and depression symptoms and certain quality of life measures.
 
Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in atopic dermatitis, and certain atopic or allergic diseases including asthma and nasal polyposis, where Dupixent is being evaluated in ongoing clinical studies.
 
“These results support the growing body of evidence for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease. The Phase 3 SOLO 1 and SOLO 2 clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated a significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures,” said Dr. Eric Simpson of Oregon Health & Science University, who was lead author of the NEJM paper. “Additionally, the reduction of itch intensity is important because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep.”
 
The NEJM paper provides data on key endpoints including:
  • At 16 weeks for SOLO 1 and SOLO 2, respectively, 37 and 36 percent of adult patients who received Dupixent 300 mg weekly, and 38 and 36 percent of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions as measured by the five-point Investigator’s Global Assessment (IGA) scale, compared to 10 and 8 percent with placebo. This was the primary endpoint of the study in the United States and one of the primary endpoints in the European Union (EU).
  • At 16 weeks for SOLO 1 and SOLO 2, respectively, 52 and 48 percent of adult patients who received Dupixent 300 mg weekly, and 51 and 44 percent of patients who received Dupixent 300 mg every two weeks, achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) compared to 15 and 12 percent with placebo. This was the key secondary endpoint in the United States and one of the primary endpoints in the EU.
  • At 16 weeks for SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received Dupixent 300 mg every two weeks, compared to 38 and 31 percent for placebo.
  • The reduction in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was a secondary endpoint that was met at two weeks, four weeks and 16 weeks. The Pruritus NRS ranges from 0 (no itch) to 10 (worst itch imaginable). At 16 weeks, for SOLO 1 and SOLO 2, respectively, 40 and 39 percent of patients who received Dupixent 300 mg weekly and 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a four-point or greater reduction in their NRS score compared to 12 and 10 percent with placebo.
The Dupixent Biologics License Application (BLA) was recently accepted for Priority Review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act target action date of March 29, 2017. The FDA granted Dupixent Breakthrough Therapy designation in uncontrolled moderate-to-severe atopic dermatitis in 2014. The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.
 
Code: E101603

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