Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Label Update for Cosentyx

Novartis news release; 2018 Feb 8

Novartis has announced that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis. Approximately half of all 125 million people with psoriasis suffer from scalp psoriasis, which can have an impact on patients' quality of life.

Indications: The updated label includes Cosentyx data in moderate-to-severe scalp psoriasis—one of the difficult-to-treat forms of the disease. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors. The update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.

Dosage/administration: Recommended dosage for plaque psoriasis is 300 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable.

Adverse effects: Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.


Novartis receives FDA approval for Cosentyx® label update to include moderate-to-severe scalp psoriasis. [news release]. Basel, Switzerland: Novartis. February 8, 2018. Accessed February 12, 2018.

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FDA Approves Label Update for Cosentyx, Novartis news release; 2018 Feb 8

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FDA Approves Stelara for Adolescent Psoriasis, Janssen news release; 2017 Oct 13