Novartis' Cosentyx Label Expanded to Include Scalp Psoriasis

Novartis NVS announced that the FDA has approved a line extension for its IL-17A inhibitor drug, Cosentyx, in moderate-to-severe scalp psoriasis. The FDA approval comes on the back of positive efficacy and safety outcomes from a dedicated phase III study – SCALP – in patients with scalp psoriasis.

We note that the drug was approved for a similar indication in Europe in June 2017. It is already approved for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (“AS”).

Per the press release, scalp psoriasis is one of the difficult to treat forms of psoriasis, which affects about half of the approximately 125 million patients with the disease. The line extension of the drug is an important achievement as treatment of scalp psoriasis with topical agents or phototherapy is challenging due to the presence of hair and other factors.

Novartis’ shares have returned 13.7% in the past year, compared to the industry’s gain of 14.1% in the same period.

 

The SCALP study evaluated the subcutaneous administration of Cosentyx (300 mg) for 12 weeks. Data showed significant improvement in patients compared to placebo.

Cosentyx’s performance was impressive in 2017. It achieved multi-blockbuster drug status on the back of strong growth in all the approved indications. Sales of the drug increased 82% in 2017 to surpass the $2 billion mark.

The drug has shown superiority in clinical studies to Johnson & Johnson’s JNJ Stelara and Amgen’s AMGN Enbrel in treating psoriasis. Novartis is also conducting head-to-head clinical trials – EXCEED and SURPASS – to evaluate the superiority of Cosentyx versus AbbVie’s ABBV Humira in PsA and to a proposed biosimilar of Humira in AS, respectively.

The superiority of the drug over Stelara and Enbrel has helped it gain market share. Potential superiority over Humira and its biosimilar along with this line extension in scalp psoriasis will certainly boost the prospect of the drug.

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Novartis carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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