Novartis Cosentyx’s first IL-17 inhibitor to receive EU approval

Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and Stelara (ustekinumab) are recommended for second-line systemic therapy in Europe[1-3].

“With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis,” said David Epstein, Division Head, Novartis Pharmaceuticals. “Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. 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 key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70 per cent or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52[5]. Data from the Cosentyx clinical trial programme also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life[6].

The EU approval follows the recent results of the Phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel (etanercept) in clearing skin in the FIXTURE study[6]. In the Phase III clinical programme the overall safety profile of Cosentyx was favourable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison[4,5].

In addition to the EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

The US Food and Drug Administration (FDA) decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

References

[1] European Medicines agency website, “Enbrel Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000262/WC500027361.pdf. Accessed November 2014.

[2] European Medicines agency website, “Humira Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000481/WC500050870.pdf. Accessed November 2014.

[3] European Medicines agency website, “Stelara Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000958/WC500058513.pdf. Accessed November 2014.

[4] Novartis, Data on file.

[5] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.

[6] .McLeod LD, Mallya UG, Fox T, Strober BE. Psoriasis Patients With PASI 90 Response Achieve Greater Health-Related Quality-of-Life Improvements Than Those With PASI 75 Response. European Association of Dermatology and Venereology, Amsterdam, Netherlands, 2014. Poster 1681.