(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication for a rare disease.
This new approval is for Ilaris (canakinumab) injection. The FDA approved it to treat active Still’s disease, which includes adult-onset Still’s disease (AOSD).
AOSD is a rare and serious autoinflammatory disease with an unknown cause.
Autoinflammatory diseases are caused by issues with the immune system. These issues cause an inflammatory response that can then damage the body's own tissues.
In 2013, canakinumab was approved for systemic juvenile idiopathic arthritis (SJIA) in patients 2 years old and older.
This medication is available as an injection to be given under the skin every four weeks.
Still's disease is referred to as AOSD in adults and SJIA in children. Still's disease is an autoinflammatory disorder that may be a result of having too much of certain proteins (including interleukin-1β) or being too sensitive to them.
Symptoms include arthritis, elevated markers for inflammation, fever and rash.
“Prior to today’s approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers and rash,” said Dr. Nikolay Nikolov, acting director of the FDA's Division of Rheumatology and Transplant Medicine, in a press release. “Today’s approval provides patients with a treatment option.”
Common side effects of canakinumab include colds and upper respiratory tract infections, stomach pain and injection-site reactions. Serious side effects include the decreased ability of the body to fight infections and the risk of infection with live vaccines.
The approval of this medication was granted to Novartis Pharmaceuticals Corp.
