Novartis' Secukinumab Maintains Efficacy In Psoriasis Trial

Novartis reported that results from a Phase 3 trial show that AIN457 (secukinumab) successfully maintained efficacy in patients with psoriasis. The company presented the results at the European Association of Dermatology and Venereology (EADV) Congress held in Amsterdam, Netherlands.

Secukinumab is a fully human monoclonal antibody (mAb) and interleukin-17A (IL-17A) inhibitor being developed for diseases that affect the immune system. The drug prevents IL-17A from fulfilling its part in the development of psoriasis.

The data was gleaned from four pivotal Phase 3 trials (ERASURE, FIXTURE, FEATURE and JUNCTURE) investigating secukinumab’s effect on moderate to severe plaque psoriasis. All four studies investigated the safety, tolerability, and efficacy of secukinumab. Data shows that most of patients achieved completely clear to almost clear skin measured from baseline in the trials. Those who were treated with secukinumab also achieved higher rates of clear to almost clear skin compared to placebo irrespective of how severe their psoriasis was. Skin clearance was consistent through one year of treatment with secukinumab.

Vasant Narasimhan, Global Head of Development at Novartis, said, “We are excited to continue seeing new positive results for secukinumab in psoriasis, this time showing consistent high rates of skin clearance regardless of disease severity, as well as the positive relationship clearing skin has on patients' quality of life.”

Earlier this year, Novartis reported similar positive results from two pivotal Phase 3 studies investigating the drug in adult onset psoriatic arthritis (PsA). The drug also demonstrated superiority to Pfizer’s plaque psoriasis drug Enbrel in the Phase 3 FIXTURE trial.

The company revealed that regulatory reviews for secukinumab are ongoing. Novartis expects a U.S. FDA advisory committee meeting as well as a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) this month. Should the drug receive clearance for the market, rival drug Enbrel could see some new competition—though secukinumab isn’t expected to steal away a majority of profits in the market. Analysts at Evaluate Pharma predicted a modest $570 million in annual sales for secukinumab by 2018 should it secure approval, PMLive reported. Enbrel currently brings in $9 billion in profits a year for Pfizer.