EMA Advisory Committee Recommends Novartis Psoriasis Drug for ApprovalBy
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic* treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic* therapy.
Secukinumab (at a dose of 300 mg) is a human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A) IL-17A is a protein found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies. It is the first IL-17A inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe, according to Novartis. Secukinumab works by inhibiting the action of IL-17A.
The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted in approximately two months of the CHMP opinion, will be applicable to all European Union and European Economic Area countries.
Secukinumab is also in Phase III development for psoriatic arthritis and ankylosing spondylitis; regulatory applications for secukinumab in these arthritic conditions are planned for 2015.