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: ankylosing spondylitis
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. * 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®. Cosentyx® will be indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
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:
