FDA Approves Ilaris to Treat 3 Rare Periodic Fever Syndromes

Andrew Black

Novartis’ drug Ilaris (canakinumab) was granted FDA approval for expanded use to treat 3 rare types of periodic fever syndromes:

The FDA approvals are based on results from a pivotal Phase III study which showed rapid and sustained disease control with Ilaris compared to placebo through 16 weeks, in patients with either TRAPS, HIDS/MKD or FMF.
Ilaris is the only FDA-approved biologic treatment for patients with these Periodic Fever Syndromes (also referred to as Hereditary Periodic Fevers (HPF). 
Because of the positive data, the FDA granted Breakthrough Therapy status and priority reviews to Ilaris for each of the 3 Periodic Fever Syndrome conditions.

About Ilaris

Ilaris is a selective, high-affinity, human monoclonal antibody that inhibits Interleukin-1 (IL-1) beta, which is an important part of the body's immune system defenses. It blocks the action of IL-1 beta for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production.

About Periodic Fever Syndromes

Periodic fever syndromes are a group of diseases that cause serious recurrent fever and inflammation through non-infectious activation of the immune system. Most patients present with symptoms in infancy or childhood, but in some patients the condition only becomes apparent or diagnosed in adulthood.


Tumor necrosis factor receptor-associated periodic syndrome (TRAPS) is a condition characterized by recurrent episodes of fever. These fevers typically last about 3 weeks but can last from a few days to a few months. The frequency of the episodes varies greatly among affected individuals; fevers can occur anywhere between every 6 weeks to every few years

About HIDS

Hyper IgD syndrome (HIDS) is a rare inflammatory genetic disorder characterized by periodic episodes or "attacks" of fever associated with additional symptoms including joint pain (arthralgia), skin rash and abdominal pain. Most episodes last several days and occur periodically throughout life. The frequency of episodes and their severity vary greatly from case to case. HIDS is associated with decreased activity of the enzyme mevalonate kinase (MVK).

About FMF

Familial Mediterranean fever (FMF) is an inherited condition characterized by recurrent episodes of painful inflammation in the abdomen, chest, or joints. These episodes are often accompanied by fever and sometimes a rash or headache. Occasionally inflammation may occur in other parts of the body, such as the heart; the membrane surrounding the brain and spinal cord; and in males, the testicles.
The first episode of illness in familial Mediterranean fever usually occurs in childhood or the teenage years, but in some cases, the initial attack occurs much later in life. Typically, episodes last 12 to 72 hours and can vary in severity. The length of time between attacks is also variable and can range from days to years.
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