Novartis obtains European approval for Cosentyx to treat psoriasis

19 January 2015 (Last Updated January 19th, 2015 18:30)

Swiss drug-maker Novartis has received approval from the European Commission (EC) for its Cosentyx (secukinumab, formerly known as AIN457) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Psoriasis

Swiss drug-maker Novartis has received approval from the European Commission (EC) for its Cosentyx (secukinumab, formerly known as AIN457) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Cosentyx is a human monoclonal antibody that selectively neutralises the interleukin-17A (IL-17A) inhibitor, which is observed in high concentrations in skin affected by psoriasis.

The drug obtained approval in Europe, and is said to offer a new first-line biologic treatment option for patients.

Including anti-tumour necrosis factor therapies (anti-TNFs) and Stelara, all biologic treatments for psoriasis are currently recommended for second-line systemic therapy in Europe.

Novartis Pharmaceuticals division head David Epstein said: "With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis.

"Clear skin may now be a reality for patients living with psoriasis."

"Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin."

The approval was based on results of the Phase IIIb Clear Study, which demonstrated that Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe plaque psoriasis, noted Novartis.

In addition, Cosentyx demonstrated superiority to Enbrel (etanercept) in clearing skin in the Fixture study.

According to Novartis, around 70% or more Cosentyx 300mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and this was maintained with continued treatment in the majority of patients up to week 52, in clinical studies.

Cosentyx was also approved in Australia to treat moderate-to-severe plaque psoriasis, and in Japan to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).


Image: Psoriasis of a thumbnail, with visible pitting. Photo: courtesy of Seenms.