FDA Approves Actemra to Specifically Treat Giant Cell Arteritis

According to a press release by the US Food and Drug Administration (FDA), Actemra (tocilizumab) has been approved for its expanded use to treat adults diagnosed with giant cell arteritis. This is the first FDA-approved therapy specifically for this type of vasculitis.

Badrul Chowdhury, MD, PhD, the director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research stated, “We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options.”

Vasculitis is a group of disorders resulting in inflammation of blood vessels that cause the arteries to narrow, resulting in a decreased amount of blood flow to the tissues. Giant cell arteritis specifically affects vessels primarily in the head, especially the temporal vessels, as well as larger arteries such as the aorta. Corticosteroids at high doses that are then tapered off over time have become the standard treatment for this disease.

The efficacy and safety of the new drug, administered subcutaneously, was established in a double-blind, placebo-controlled study with 251 patients diagnosed with giant cell arteritis. The primary efficacy endpoint was established as the proportion of patients achieving sustained remission, defined as the absence of symptoms of the disease, normalization of inflammatory laboratory tests, and tapering off prednisone, from week 12 to week 52.

The study found that a greater proportion of patients receiving Actemra, in conjunction with standardized prednisone regiments, had achieved sustained remission from week 12 to week 52 when compared with patients receiving standardized prednisone regimens and a placebo.

Actemra is associated with a boxed warning for serious infections, in which treatment with this medication should be halted immediately until the infection is controlled, as well as avoidance from live vaccines. A potential adverse effect associated with this medication includes hypersensitivity reaction (ie, anaphylaxis and death), and laboratory monitoring of neutrophils, platelets, lipids, and liver function tests is recommended. This drug should be used in caution with patients at increased risk for gastrointestinal perforation.

Summary & Clinical Applicability

Actemra (tocilizumab) has been approved for its expanded use to treat adults diagnosed with giant cell arteritis, the first in its class.

Giant cell arteritis specifically affects vessels primarily in the head, as well as larger arteries such as the aorta.

A greater proportion of patients receiving Actemra, in conjunction with standardized prednisone regiments, had achieved sustained remission from week 12 to week 52.

A boxed warning is associated with Actemra for patients with serious infections; live vaccines should be avoided, and its use should be cautioned in patients with increased risk for gastric perforation.

Adverse effects include hypersensitivity reaction (ie, anaphylaxis and death), and routine laboratory tests are recommended (ie, neutrophils, platelets, lipids, and liver function tests).

The FDA granted the supplemental approval of Actemra to Hoffman La Roche, Inc.

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Reference

FDA approves first drug to specifically treat giant cell arteritis. Silver Spring, MD: US Food and Drug Administration; May 22, 2017.