Novartis Wins FDA Approval In The U.S. To Sell Its Psoriasis Drug Cosentyx

On January 21, 2015 Novartis AG (NVS) announced that it had received FDA approval for its psoriasis drug secukinumab that will be marketed under the name Cosentyx. This FDA approval comes after an FDA advisory panel met back in October of 2014 and concluded that secukinumab should be approved for this patient population. The FDA does not have to follow the FDA advisory panel's recommendations, but typically that's exactly what the FDA does. There have been some instances where the FDA has gone against the FDA advisory panel, although very rare. 

Psoriasis is a skin disease affecting about 120 million people worldwide, which makes it  a huge market to go after. In fact the drug is expected to produce up to $1 billion per year and may become a blockbuster drug. However, Novartis has a lot of competition in the similar space, for instance  Amgen's (AMGN) Enbrel, Abbvie's (ABBV) Humira, and Johnson & Johnson's (JNJ) Stelara. 

Cosentyx is a new form of treatment for plaque psorasis that blocks a protein known as IL-17. By blocking the IL-17 protein it inhibits the production of an inflammation effect on the skin, which in turn causes a reduction of psoriasis on the skin and could potentially help patients to obtain clearer skin.

Shares of Novartis remained flat on the news but the market opportunity for Cosentyx is in the billions so there is no doubt that it will bring in a lot of revenue over time thus revaluing the company's current share price. The drug is still being studied to treat psoriatic arthritis; another golden opportunity for Cosentyx would be the opportunity to be able to receive approval for another large target market indication, Rheumatoid arthritis, which is what Novartis is also currently pursuing.

Disclosure: No positions in any stocks mentioned

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Kate Monroe 10 years ago Member's comment

The stock climbed substantially earlier in the week, seemingly before the European approval - what do you think accounts for that, and where do you see it leveling off in the near term?

Joe Black 10 years ago Member's comment

Where are they in the process of approval for psoriatic arthritis - I would imagine they are closer on that than on rheumatoid?