FDA approves Genentech’s Actemra for giant cell arteritis

Sixth FDA approval for Actemra since its US launch 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 Sandra Horning, chief medical officer and head of Global Product Development. “With no new treatments in more than 50 years, this approval could be transformational for people with GCA and for their physicians.”

The approval is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in patients with GCA. The results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56% in the Actemra weekly group and 53.1% in the Actemra bi-weekly group) compared to placebo combined with a 26-week steroid taper (14%) and placebo combined with a 52-week steroid taper (17.6%).