The U.S. Food and Drug Administration (FDA) has permitted the use of subcutaneous Actemra (tocilizumab) to assist adults who are receiving treatment for giant cell arteritis.
Giant cell arteritis has been described as a condition that can ultimately cause inflammation of blood vessels. This subsequently leads to irregular arteries and a negative impact on the blood flow. This medication is the first of its kind.
“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,” Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said.
During the research phase, 251 patients who have been diagnosed with giant cell arteritis particpated in the placebo-controlled study to evaluate if the drug could grant patients sustained remission from Week 12 through Week 52. As for the results, a majority of the patients who received subcutaneous Actemra with regular prednisone regimens and a lower dosage did achieve the goal compared to their counterparts who received the placebo with standardized prednisone regimens.
Actemera has also been granted a seal of approval for safety, but it does have a Boxed Warning for infections it could cause. Subcutaneous Actemra and Intravenous Actemra were approved to treat severe active rheumatoid arthritis.
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