The biologic dupilumab, which could be FDA-approved as early as April 2017 for sale by Sanofi and Regeneron Pharmaceuticals, Inc, under the brand name Dupixent, made headlines with another positive study indicating that the investigational human monoclonal antibody (mAb) intended to treat moderate-to-severe atopic dermatitis (AD) shows “sustained efficacy in reducing signs and symptoms and improving skin lesions and pruritus among AD patients without any major safety issues.”
Lead author on the study, Mette Deleuran, PhD, professor in the Dermatology Department at Aarhus University Hospital in Aarhus, Denmark, and her team revealed their results in a late-breaking abstract session at the 2017 annual American Academy of Asthma, Allergy, and Immunology (AAAAI) meeting in Atlanta, Georgia, on March 6. Deleuran and her team presented the first-step analysis from an ongoing phase 3 multi-center, open-label trial of subcutaneous dupilumab that Elias Zerhouni, former head of the National Institutes of Health and current Sanofi Pasteur head of Research & Development, described as “an illustration of something more profound [than a single-product success], which is really the emergence of a new science and portfolio at Sanofi.” He went on to call dupilumab the “prototype of future medicine” in an interview with Reuters because it is designed to target 2 different disease pathways at the same time: cytokines IL-4 and IL-13, both of which are believed to signal the body’s immune system to respond, resulting in inflammation and symptoms typical of the disease.
Although Sanofi is waiting on specific approval for dupilumab for treating atopic dermatitis, effective inhibition of these cytokines and the immune responses that they trigger would indicate broader reach of the drug. From a profit standpoint, it could solidify the potential in the biosimilar sector, demonstrating that the success of a single drug for a single purpose opens up what Zerhouni calls “a pipeline in a single drug,” since many of these cytokines play a role in everything, from seasonal allergies to cancer.
According to the study, adults with moderate-to-severe AD who had participated in previous dupilumab trials were eligible to participate in phase 3 of the trial. Of the 1491 patients (60% male, with an average age of 39.7 years) who received treatment, 106 withdrew from the study during a 1-year perios. There were no deaths reported in the study. “The most common adverse events (AEs) were nasopharyngitis (20.5% of patients), upper respiratory tract infection (9.5%), exacerbation of the condition (8.2%), and conjunctivitis (all etiologies 10.7%)” the team reported. Patients who withdrew cited AEs, with the most common being nasopharyngitis, headaches, and upper respiratory tract infections. At the week-52 assessment in the study, 48.6% of patients had a score between 0 and 1 on the Investigator’s Global Assessment (IGA) scale for their symptoms with a “1” score being “almost clear” and a “0” being “clear;” 75.4% achieved ≥75% in eczema area and severity, and their pruritus scores decreased by 62.24%. The patients came from multiple parent studies and efficacy did not differ across the board.
Sanofi spent about $5.47 billion on research and development last year, all of which could pay off once dupilumab is approved for marketing in the United States this year. According to Zerhouni, biologic drugs account for two-thirds of Sanofi’s pipeline of experimental medicines, and if dupilumab is approved, it is likely that Sanofi, which has been considered somewhat of a laggard in recent years in the research-and-development sector, could suddenly find itself setting the precedent for future spending allocations across the industry, despite the fact that biologics have been considered a bigger risk than traditional pharmaceuticals because they are more expensive to develop, manufacture, and get approved. The next step will be to “persuade healthcare providers to pay for dupilumab,” observed Reuters reporter Ben Hirschler. However, such difficulties could be well worth it if the drug company finds itself not only leading the pack in eliminating AD symptoms, but also ahead of the game as a result of dupilumab in many other areas of treatment as well.