Type of information: Granting of a Market Authorisation in the EU
Product name: Cosentyx® (AIN457)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
- monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody being investigated for diseases that affect the immune system. Secukinumab stops a protein called interleukin-17A (IL-17A) from its involvement in the development of psoriasis. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies.
Company: Novartis (Switzerland)
Disease: psoriatic arthritis
- • On January 15, 2016, Novartis announced that the FDA has approved Cosentyx® (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Cosentyx® is the first in the new class of medicines called interleukin-17A (IL-17A) inhibitors to treat both AS and PsA. The two new indications follow the earlier FDA approval for Cosentyx® in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis, and European approval for AS and PsA in November 2015. The approvals are based on the efficacy and safety outcomes from four placebo-controlled Phase III studies, which included over 1,500 adult patients with AS or PsA that were biologic treatment naïve or had an inadequate response / were intolerant to anti-TNFs. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 20*) at Week 16, and a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, respectively. ASAS 20 and ACR 20 are standard tools used to assess clinical improvement in AS and PsA.
- • On October 22, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for Cosentyx®. The CHMP adopted new indication for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.
- • On December 26, 2014, Novartis announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx® (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who are not adequately responding to systemic* therapies (except for biologics). This approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan. Cosentyx® works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA. As approximately 30% of psoriasis patients are also affected by PsA globally, this approval means that these patients in Japan now have a new treatment option that effectively treats both diseases.
- In psoriasis clinical trials, 70% of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx® 300 mg (p<0.0001), which was maintained in the majority of patients up to Week 52 (with continued treatment). In the PsA trials, Cosentyx® demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of PsA, as measured by a 20% reduction in the American College of Rheumatology response criteria (ACR 20), which is a standard criteria to assess the effectiveness of arthritis treatments. Between 50% to 54% of Cosentyx patients achieved at least ACR 20 in two pivotal studies, FUTURE 1 (150 mg; p<0.0001) and FUTURE 2 (150 and 300 mg; p<0.0001).
- This approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA. In all studies, Cosentyx®demonstrated a favorable safety profile, with similar incidence and severity of adverse events (AEs) between Cosentyx® treatment arms (300 mg and 150 mg). Phase III development for psoriatic arthritis and ankylosing spondylitis is also underway; global regulatory applications for Cosentyx® in these arthritic conditions are planned for 2015.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-01-15
UE authorization: 2015-11-19
Favourable opinion UE: 2015-10-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
- • On October 26, 2018, Novartis announced that the European Commission (EC) has approved a label update for Cosentyx® (secukinumab). The new label update includes dosing flexibility of up to 300 mg based on clinical response that will provide clinicians with greater choice for their patients. The label update also includes 24-week structural data with subcutaneous (sc) regimens demonstrating that Cosentyx inhibits progression of joint damage in psoriatic arthritis.
- The label update is based on Cosentyx sustained efficacy and consistent safety following up-titration to 300 mg in PsA. Cosentyx specifically inhibits IL-17A - a cornerstone cytokine involved in the development of spondyloarthritis and psoriatic disease. The 24-week structural disease progression data are from FUTURE 5, the largest Phase III study for a biologic conducted in PsA to date (996 patients). In this study, almost 90% of patients treated with Cosentyx 300 mg had no radiographic disease progression at 24 weeks.
- The label update is applicable to all European Union and European Economic Area countries and is effective immediately.