Novartis to seek approval for potential psoriatic arthritis blockbuster
- Secukinumab is an interleukin-17A inhibitor that is currently being evaluated by the FDA for the treatment of psoriatic arthritis (PsA).
- In a phase III study involving more than 1,000 patients, secukimumab met all of its primary endpoints, including changes in peripheral joint disease and the ability to prevent joint damage. All responses showed significant improvements versus placebo.
- Secukinumab also delivered "clear" or "almost clear" skin.
Seckunimab was submitted to both the FDA and the European Medicines Agency (EMA) at the end of 2013 for evaluation as a treatment for moderate-to-severe plague psoriasis. Approvals are anticipated in both markets by early 2015 at the latest. Novartis is also testing secukunimab for treatment of ankylosing spondylitis and rheumatoid arthritis.
The market for PsA drugs and related conditions, including plague psoriasis and ankylosing spondylitis, has become increasingly competitive as various companies seek approval for their treatments. Yesterday, Celgene received approval from the FDA for Otezla (apremilast) for the treatment of moderate-to-severe plague psoriasis. Earlier this year, the oral drug was approved for treatment of PsA and is currently in clinical trials for ankylosing spondylitis.
One reason that there is so much play in this market now is because of widespread dissatisfaction with current treatments. The mainstay of treatment for PsA and related conditions are the tumor necrosis factor (TNF) blockers, including Humira (adalimumab) and Remicade (rituximab). Despite their effectiveness for many patients, these TNF-blockers also have potentially serious side effects. Estimates for the size of the total market of PsA, psoriatic plague psoriasis, and ankylosing varies widely, but one thing is clear: Any approved drug in this market has the potential for blockbuster sales.