Novartis has revealed that the drug Cosentyx (secukinumab) - developed for the treatment of autoimmune conditions - has gained approval for ankylosing spondylitis (AS) and psoriatic arthritis (PsA) from the EMA. As an anti-interleukin (IL)-17 monoclonal antibody (mAb), Cosentyx is the only marketed anti-IL-17. It is also the first non-anti-tumour necrosis factor (TNF) biologic approved to treat AS, giving the drug a competitive edge in the market.
Characterized by stiffness and discomfort in the lower back, AS is an autoimmune disorder caused by inflammation of the axial skeleton.It is now acknowledged that the pathological changes that lead to ankylosis develop over time, with the early stage of the disease known as non-radiographic axial spondyloarthritis (nr-axSpA). Furthermore, Nr-axSpA, together with AS, form the condition axial spondyloarthritis (axSpA) with the standard of care involving either treatment with nonsteroidal anti-inflammortories (NSAIDs), or anti-TNF agents for the patients who fail on an NSAID.
As it stands, axSpA patients who are intolerant of anti-TNFs have few options. Interestingly, this contrasts from autoimmune diseases like rheumatoid arthritis, where anti-TNFs are one option among six different mechanisms of action (MOAs), collectively. Experts interviewed by GlobalData agree that there is a pressing need for additional MOAs for axSpA.
Cosentyx is likely to garner blockbuster status, as it now has three approved indications in Europe, the first of which was for psoriasis, which was received in January 2015. Additionally, it was approved by the Food and Drug Administration (FDA) in January 2015 for psoriasis, and also by Japan's Ministry of Health, Labour and Welfare (MLHW) in December 2014 for psoriasis and PsA. GlobalData believes that approval of Cosentyx in the 7MM (US, 5EU [France, Germany, Italy, Spain, UK], and Japan) for PsA is likely, and that it will also likely gain approval for axSpA in the US and 5EU.
While Cosentyx has the first-to-market advantage within its class, there are two additional anti-IL-17 agents in the pipeline, Eli Lilly's ixekizumab and AstraZeneca/Valeant's brodalumab, which are both in development in the 7MM for psoriasis and PsA. However, neither of these compounds arein development for axSpA, as the trials for both compounds in this indication were withdrawn due to operational issues for Lilly's compound, and because of a controversial association of brodalumab with suicidal ideation, causing a split in the development partnership between Amgen and AstraZeneca earlier last year. While it is unknown whether the respective pharma companies will pursue a label expansion for their anti-IL-17 drugs to axSpA, the lag in their development is a significant boon to Cosentyx.
Within the axSpA market, Cosentyx's greatest competition will be Johnson & Johnson's (J&J's) Stelara (ustekinumab), which is currently recruiting for three Phase III trials in both AS and nr-axSpA. While GlobalData believes that Cosentyx will be used off-label in patients with nr-axSpA, the reimbursement landscape would be more favorable with an official approval. At this time, there are no drugs approved by the FDA for nr-axSpA, leaving room for drug companies looking to establish an early presence. Novartis has already looked to secure its position in the nr-axSpA market, with an expected filing date in 2018, upon completion of the Phase III clinical trials.
Novartis' strategy of pursuing an AS indication early in Cosentyx's lifecycle is likely to pay off in the long term, as there may be a flood of compounds entering the axSpA market over the next few years. Based on the pathophysiology of axSpA, GlobalData expects that IL-17 inhibitors, janus kinase (JAK) inhibitors, IL-23 inhibitors, and J&J's dual IL-12/IL-23 inhibitor, Stelara, are all likely contenders. GlobalData forecasts Cosentyx's sales for axSpA at $300.8m in the 7MM in 2024, but this number may be higher if Cosentyx also gains approval for nr-axSpA.