New Indications for Psoriasis Drug Cosentyx Receive FDA Nod

January 18, 2016
Amy Jacob

Biologic drug secukinumab (Cosentyx/Novartis), already FDA approved in January 2015 to treat chronic plaque psoriasis, has now been approved for two new indications: the treatment of active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Biologic drug secukinumab (Cosentyx/Novartis), already FDA approved in January 2015 to treat chronic plaque psoriasis, has now been approved for two new indications: the treatment of active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Cosentyx is now the first and only interleukin-17A (IL-17A) antagonist approved for AS and moderate to severe plaque psoriasis and PsA.

The latest approval followed outcomes from two placebo-controlled phase III studies involving more than 1,500 adult patients suffering from either AS or PsA.

According to the results, Cosentyx successfully relieved individuals from both skin and joint symptoms — approximately half the patients experienced at least a 20% improvement in their PS compared with the 15% patients on placebo.

Similarly, nearly two-thirds patients saw at least a 75% improvement in their skin psoriasis.

Furthermore, in other clinical trials for the dug, more than 50% of patients administered Cosentyx experienced clear or almost clear skin.

According to both trials, the most commonly reported adverse events included the common cold and headache.

Christi Shaw, US Country Head, President at Novartis Corporation and Novartis Pharmaceuticals Corporation, said in a news release, “We were inspired by patients to pursue new indications for AS and PsA, because these diseases can result in significant pain and impede the simplest of tasks in a person’s daily life. The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors.”