Advisors to the European Medicines Agency have voted to support approval of Novartis’ psoriasis drug secukinumab.
Specifically the agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of secukinumab as a first-line treatment of moderate-to-severe plaque psoriasis. The Swiss major will market the drug as Cosentyx.
Secukinumab, a selective interleukin-17A inhibitor, was recommended for approval by the CHMP’s counterparts at the US Food and Drug Administration a month ago. Treatment with the drug has resulted in high rates of clear to almost clear skin at week 12 and it has shown superiority to Amgen’s Enbrel (etanercept), an anti-TNF standard of care.
Gayathri Perera at the West Middlesex University Hospital NHS Trust said that “for too long people with psoriasis have had to live with the disruptive consequences of poorly controlled symptoms, and the fear of things getting worse. The good news is that the tide is changing and new treatment options are in reach”.
Dimitrios Georgiopoulos, UK medical director at Novartis, noted that this country “has played a significant role in the R&D of this compound” and the firm’s “commitment to the anti-IL17A pathway continues with a number of ongoing trials studying secukinumab in further inflammatory conditions”. Earlier this week, promising data on the compound was presented at the American College of Rheumatology meeting in Boston for psoriatic arthritis and ankylosing spondylitis.
Helen McAteer, chief executive of the Psoriasis Association, said psoriasis is “so much more than just a skin condition; it is a serious, chronic, inflammatory disease which is associated with numerous co-morbidities and really impacts on the lives of those living with it”. She added that “this will bring new hope for many people with psoriasis, those who may have given up treating psoriasis in the past, and for people not achieving satisfactory results with their current therapy”.