Genentech announced that the FDA has accepted the company’s supplemental biologics license application for Actemra (tocilizumab) for the treatment of giant cell arteritis (GCA). The FDA also granted priority review designation for Actemra for the treatment of GCA. The designation is based on the positive outcome of the phase 3 GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a 6-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a 6- or 12-month steroid taper regimen given alone in people with GCA.
“This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible.”
Priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.
In October 2016, Genentech announced it recieved breakthrough therapy designation for the treatment of GCA with Actemra. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of substantial clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.
About the GiACTA study
GiACTA (NCT01791153) is a phase 3, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary and key secondary endpoints were evaluated at 52 weeks.