pharmafileSeptember 26, 2017
Sanofi, along with its speciality care global business unit Sanofi Genzyme, are celebrating the news that NICE has passed its final appraisal determination on the company’s Kevzara (sarilumab), recommending its use in combination with methotrexate in the treatment of severe, active rheumatoid arthritis (RA) in adults who have not responded inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (DMARDs).
This brings the company closer to marketing Kevzara in England and Wales. The decision was influenced by the drug’s results in two placebo-controlled studies and one active comparator-controlled study, where it demonstrated, "clinically meaningful improvements…reducing signs and symptoms experienced by people with RA and improving physical function compared with another biological therapy."
A fully human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), Kevzara blocks pro-inflammatory mediated signalling of IL-6, a protein that can contribute to both the pathological inflammation and joint destruction that are associated with RA. The drug has already secured EU marketing authorisation in the same indication.
"Over the years, we have made great progress in the diagnosis and management of RA, yet many patients still do not achieve symptom control despite the treatment choices available. NICE’s recommendation of sarilumab is good news for people with RA and their specialists as it potentially adds another treatment option," said Professor Ernest Choy, Consultant Rheumatologist, University of Cardiff. "Rheumatoid arthritis is an unpredictable chronic disease. It strikes at any age, often during working life. It causes severe pain and comorbidities, which can have a huge impact on all aspects of their daily life including psychological wellbeing."
Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme, added: "This recommendation brings us one step closer to making Kevzara available to adult patients with severe RA and reinforces Sanofi’s ongoing commitment to helping people impacted by often complex, misunderstood and debilitating diseases."
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