The FDA has approved Novartis AG's new plaque psoriasis therapy, Cosentyx (secukinumab), just days after European regulators approved the therapy, making the potential blockbuster the first interleukin-17 blocker to be approved for the indication.

"With the very strong phase III results, and phase III [studies] that show head-to-head against Enbrel and Stelara superiority, this thing, we believe, will be a blockbuster for Novartis in psoriasis alone," said Novartis CEO Joe Jimenez during the recent J.P. Morgan Healthcare Conference in San Francisco.

Novartis won Cosentyx approval in Japan in December 2014, gaining an regulatory OK to sell the treatment for both psoriasis and psoriatic arthritis, an effort it's pursuing with its Osaka-based marketing partner Maruho Co. Ltd.

The Basel, Switzerland-based company's multi-market lead gives it a jump on market competitors working on their own IL-17 therapies, including Eli Lilly and Co.'s ixekizumab, due for regulatory submissions in the first half of this year, and Amgen Inc.'s Astrazeneca plc-partnered brodalumab, which turned in a strong performance in a second pivotal phase III study in November. The approval also opens the door for Novartis to pursue two additional indications in the U.S. and Europe this year: psoriatic arthritis and ankylosing spondylitis, areas in which it presented top-line results last year. (See BioWorld Today, Nov. 13, 2014.)

Novartis spokesman Eric Althoff told BioWorld Today that the drug will be available in the U.S. within the next couple of months while pricing information would probably be established in the next couple of weeks.

About 2.6 million Americans, or about 43.8 million people worldwide have plaque psoriasis, a chronic immune-mediated disease that can cause itching, scaling and pain. Nearly 35 percent of psoriasis patients suffer from the moderate-to-severe form of the condition.

Cosentyx selectively binds to and inhibits the inflammation-linked protein IL-17A, to treat moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The FDA approval for a 300-mg dose of the medicine was based on safety and efficacy data from four phase III placebo-controlled studies which examined 300-mg and 150-mg doses of Cosentyx in patients with moderate-to-severe plaque psoriasis. Participants were randomly assigned to receive Cosentyx or a placebo. Data from the studies showed that Cosentyx achieved greater clinical response than the placebo, with skin that was clear or almost clear, as assessed by scoring the extent, nature and severity of psoriatic changes of the skin.

The FDA approval came with the caveat that patients taking it be given guidance that, because it affects the immune system, they may have a greater risk of getting an infection. Serious allergic reactions have been reported with the therapy's use. The FDA noted that caution should be exercised when considering its use in patients with a chronic infection or history of recurrent infection, and in patients with active Crohn's disease. The most common side effects include diarrhea and upper respiratory infections.

Cosentyx gained unanimous support from the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee in October. Members mostly favored Novartis' post-marketing plan to create a disease registry powered to detect malignancies, including at least 2,000 patients exposed to secukinumab, 2,500 given biologics and 500 getting other systemic medications.(See BioWorld Today, Oct. 21, 2014.)

The label expansions, if successful, could "drive this product to a multi-billion dollar blockbuster status at peak," said Novartis' pharmaceuticals division head David Epstein during the company's Oct. 28 third quarter earnings call. A Thomson Reuters Cortellis consensus forecast, drawing from five analysts, predicts the therapy will generate about $1.1 billion in peak annual sales by 2019.

Novartis' American depository receipts (NYSE:NVS) fell $2.73 Wednesday to $98.75.