Novartis receives two new FDA approvals

Novartis announced that the US Food and Drug Administration (FDA) has approved Cosentyx^® (secukinumab) for the treatment of two new indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

Cosentyx is the first in a 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.

In the US, it is estimated that up to 0.5% of the population have AS, and up to 1% live with PsA. If not treated effectively, these conditions can lead to irreversible damage to the spine and joints, causing life-long pain and disability that can have a negative impact on even simple tasks in life. There is an urgent unmet need for new medicines for these conditions. Currently many patients are dissatisfied with their treatments, and up to 40% do not respond sufficiently to anti-tumor necrosis factor-alpha (anti-TNFs) therapy.

Novartis announces efficacy of Cosentyx in ankylosing spondylitis patients

Novartis announced that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in the New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in the signs and symptoms of active AS - a long-term, painful and debilitating inflammation of the spine. Collectively the studies form the largest clinical trial program ever conducted in AS, involving 590 patients.

 

In both studies, the primary endpoint was the proportion of patients with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16 with Cosentyx 150 mg. ASAS 20 response rates with Cosentyx 150 mg vs placebo at Week 16 were 60.8% (vs 28.7%, p<0.001) for MEASURE 1 and 61.1% (vs 28.4%, p<0.001) for MEASURE 2[2]. The studies enrolled anti-tumor necrosis factor (anti-TNF) naïve patients and patients who had previously failed anti-TNF therapy, with clinical benefits demonstrated across the trial populations.

Clinical improvements were seen as early as Week 1 and were sustained throughout the studies, with up to 77% of patients achieving an ASAS 20 response at the end of Week 52. Efficacy assessments, except those at Week 16, were exploratory endpoints.

Cosentyx is the first IL-17A inhibitor to demonstrate efficacy in Phase III AS studies and was recently approved in Europe to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs). New treatment options are needed for patients who do not achieve an adequate response to NSAIDs or anti-TNFs, with up to 40% of patients not responding sufficiently to the latter.