Date: 2016-01-15
Type of information: Granting of a Market Authorisation in the US
Product name: Cosentyx® (AIN457)
Compound: secukinumab
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Action mechanism: 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
Latest news: * 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[1]. 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[1]. 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.
Patents:
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: OTC status: Other news:
