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FDA Grants Priority Review for Actemra to Treat Giant Cell Arteritis
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The FDA has accepted Genentech’s supplemental biologics license application and has granted priority review for Actemra in the treatment of giant cell arteritis, according to a company press release.
“This positive outcome in [giant cell arteritis] 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 at Genentech, said in the release.
In October, Actemra received the FDA’s Breakthrough Therapy designation for GCA.
Results from the phase 3 GiACTA study of 251 patients showed Actemra initially combined with a 6-month glucocorticoid led to sustained remission of GCA through 1 year compared with a 6-month or 12-month steroid taper regimen alone.
“We are pleased by the FDA’s decision to classify their review of the [supplemental biologics license application] sBLA as priority,” Horning said. “We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible.”
Reference:
www.gene.com/media/press-releases/14653/2017-01-23/fda-grants-priority-review-for-genentech