Novartis Eyes Fourth Approval For Cosentyx

As Novartis files Cosentyx for non-radiographic axial spondyloarthritis, it is becoming increasingly clear that psoriasis will not be the blockbuster's revenue growth driver going forward.

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Cosentyx could soon be approved for four indications

The steep revenue rise Novartis AG has been enjoying with Cosentyx is set to continue with the Swiss major filing for a fourth indication, non-radiographic axial spondyloarthritis (nr-axSpA).

Novartis has announced additional positive topline data from the ongoing 555-patient Phase III PREVENT trial which showed that Cosentyx (secukinumab) met its primary endpoint of ASAS40, ie an improvement of at least 40% in disease activity, at week 52 versus placebo. The symptoms assessed included pain, function, and inflammation such as morning stiffness.

Detailed results planned to be presented at a future scientific congress but Novartis noted that the 52 week data confirming Cosentyx's efficacy in nr-axSpA will trigger a filing with the US Food and Drug Administration. A submission has already been made to the European Medicines Agency on the basis of positive 16-week PREVENT data which were announced mid-September.

Cosentyx, an interleukin-17A (IL-17A) inhibitor, was first approved for psoriasis in 2015, with approvals following for psoriatic arthritis (PsA) and ankylosing spondylitis (AS) soon after. It has quickly become the company's biggest seller, bringing in $858m in the second quarter this year, up 22% on the like, year-earlier period.

In April this year, Novartis CEO Vas Narasimhan told Scrip that the drug was growing for both dermatology and rheumatology indications. However the latter segment is growing the faster of the two, given the fiercely competitive psoriasis market. Much of the competition is coming from the IL-23 inhibitors - Johnson & Johnson's Tremfya (guselkumab), Sun Pharmaceutical Industries Ltd.'s Ilumya (tildrakizumab) and the recently-approved Skyrizi (risankizumab) from AbbVie Inc..   (Also see "Sun’s Ilumya Ramps Up In Skyrizi’s Shadow" - Scrip, 14 Aug, 2019.)

Novartis is aiming to remain as the leading IL-inhibitor in the space by focusing on the axial spondyloarthritis (axSpA) market, which is roughly half AS, in which joint damage is generally visible on x-ray, and half nr-axSpA, which isn't. There are approximately 1.7 million patients with nr-axSpA in the US and Europe; both axSpa diseases are underserved and the markets have the potential to significantly increase.

Cosentyx has been directly competing with Eli Lilly & Co.'s IL-17 inhibitor Taltz (ixekizumab) since the latter won FDA approval to treat psoriasis in 2016. Taltz, which gained an indication for PsA in 2017, also got approved for AS in August this year, so Lilly now also has three approvals.  (Also see "Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line" - Scrip, 26 Aug, 2019.)

Furthermore, in April this year, Lilly presented positive data from the COAST-X trial, supporting the firm's belief that Taltz could become the first IL-17A antagonist to be approved for nr-axSpA. At the time, the company said it planned to submit the data to regulatory authorities in 2019 but when asked by Scrip if  submissions had been filed yet, Lilly stated that it doesn’t provide further comments on "financial projections/performance or future market access for our products or therapy areas outside of our quarterly earnings calls."  (Also see "Taltz Results In Spondyloarthritis Add To Lilly Franchise Hopes" - Scrip, 23 Apr, 2019.)

Novartis feels that the five years of clinical data it has compiled supporting the long-term efficacy and safety of Cosentyx across all the indications sets it apart from the competition. Prescriber familiarity with the product should also make for a smooth launch in nr-axSpa and in an interview with Scrip in June, Eric Hughes, global development head of immunology, hepatology and dermatology, stressed that the data generated thus far shows that IL-17A "really is the key cytokine of the inflammatory process" for these indications. (Also see "Novartis MAXIMISEs Cosentyx PsA Position" - Scrip, 13 Jun, 2019.)

Many observers believe there is more to come from Cosentyx and in an investor note in August, analysts at Jefferies argued that the drug's "ongoing momentum seems underappreciated." They have forecast sales of $5.9bn by 2022, about $1.2bn ahead of consensus.

The broker acknowledged the "intensifying competition in psoriasis" but believed it would be "more than offset by continued growth in PsA and AS, "as well as the significant opportunity in nr-axSpa." The analysts said that "there are fewer competing new therapies in these diseases and substantially greater potential for increased use of biologics versus psoriasis, which itself lags arthritis."

Jefferies is forecasting worldwide peak sales for Cosentyx of around $9bn. In the US, the analysts expect psoriasis sales to decline 5% per year, contributing 20% to total sales in 2022, down from over 50% in 2018.