Genentech’s arthritis drug, Actemra (tocilizumab), was approved by the FDA on Monday to treat adults with giant cell arteritis (GCA). This represents the sixth FDA-approved indication for Actemra since it was launched in the US in 2010.
“Today’s FDA decision means people living with giant cell arteritis will, for the first time, have an FDA-approved treatment option for this debilitating disease,” said Dr. Sandra Horning, chief medical officer and head of global product development for Genentech. “With no new treatments in more than 50 years, this approval could be transformational for people with GCA and for their physicians.”
Giant cell arteritis is a chronic and severe form of vasculitis, which is characterized by inflammation of blood vessels in the body. The disease primarily affects the temporal arteries and other blood vessels in the head, which narrow as a result of chronic inflammation and impedes normal blood flow.
It’s estimated that 228,000 people in the US are affected by giant cell arteritis, all of which are over the age of 50. Currently, patients with giant cell arteritis are treated with corticosteroids to reduce inflammation, however this standard treatment presents its own side effects, and was never tested in placebo-controlled clinical trials.
The results of the Phase III GiACTA clinical trial were used to support the FDA’s decision to approve the drug. In all, 251 patients with giant cell arteritis were enrolled in the late-stage clinical trial, with more patients given Actemra achieving sustained remission while tapering their dose of prednisone, compared to those in the placebo group.
According to the FDA, the safety profile for Actemra was consistent with previous studies of the drug. Actemra does carry a boxed warning for serious infections, and some patients have experienced anaphylaxis resulting in death after being treated with the biologic.
Genentech’s Actemra is a humanized interleukin-6 (IL-6) receptor antagonist, which is either administered via subcutaneous or intravenous injection. The biologic has previously been approved to treat moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis.