(RxWiki News) The US Food and Drug Administration (FDA) has approved the first treatment for a specific type of vasculitis.
This new approval is found under the brand name Actemra (tocilizumab). The FDA approved it to treat adults with giant cell arteritis, a form of vasculitis. Vasculitis is a group of disorders that result in inflammation of blood vessels.
This inflammation narrows the arteries, which then affects blood flow. In giant cell arteritis, the blood vessels that are most involved are those of the head. However, other blood vessels, such as the aorta, can become inflamed.
But Tocilizumab, which is available as an injection, may help with that, according to the FDA. The FDA’s approval of the drug came after a double-blind, placebo-controlled study that looked at 251 patients. This research found Tocilizumab to be safe and effective.
Tocilizumab carries a boxed warning noting the risk for serious infections. Because of this risk, live vaccines should be avoided during treatment with this medication.
Your health care provider will monitor your neutrophils (a type of white blood cell), lipids, liver function and platelets during treatment.
Actemra was previously approved to treat several types of rheumatoid arthritis.
Hoffman La Roche manufactures Actemra.