FDA Greenlights Two Novartis Drugs, Including First for Adult-Onset Still’s Disease

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Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin. The Swiss pharma giant won approval for Ilaris (canakinumab), which was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

In its approval, the U.S. Food and Drug Administration approved Ilaris for the disease whose symptoms can include painful arthritis, fevers and rash. Characteristics of AOSD have considerable overlap with SJIA, for which Ilaris was previously approved. In its approval, the FDA said the overlapping features of AOSD and SJIA suggest this is a disease continuum rather than two separate diseases.

The prevalence of AOSD is estimated to be less than one case per 100,000 people. AOSD can be challenging to diagnose due to those highly variable symptoms, which can also include high spiking fever, muscle pain, and sore throat, among others. The condition is generally equally distributed between genders, primarily impacting young adults between the ages of 16 and 35.

Victor Bultó, president of Novartis Pharmaceuticals Corporation, said the company is proud that Ilaris has broken through and become the first FDA-approved treatment for AOSD.

“At Novartis, we are committed to bringing medicines that address high unmet needs to patients, including to those who are living with rare diseases,” he said in a brief statement.

Ilaris is an IL-1B inhibitor. In its announcement, the FDA noted that the role of interleukin-1 is well-established in AOSD and SJIA. Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder.

The safety and efficacy of Ilaris for the treatment of patients with AOSD was established using comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with SJIA, as well as the safety of canakinumab in patients with AOSD and other diseases. Efficacy of ILARIS was also assessed in a randomized, double-blind, placebo-controlled study that enrolled 36 patients (22 to 70 years old) diagnosed with AOSD.

In addition to the approval of Ilaris for AOSD, Novartis’ Cosentyx also won approval for a new indication to treat active non-radiographic axial spondyloarthritis, a disease characterized by inflammatory arthritis of the spine associated with chronic inflammatory back pain. FDA approval for Cosentyx is based on the Phase III PREVENT trial, which demonstrated the efficacy of Cosentyx in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum. In that study, Cosentyx met the primary endpoint achieving statistically significant improvements in the signs and symptoms of nr-axSpA. There are approximately 2.7 million patients with nr-axSpA in the United States and European Union, Novartis said.

This approval marks the fourth indication for Cosentyx. The IL-17A inhibitor has also been approved to treat severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

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