Uncategorized
FDA grants breakthrough therapy designation to Actemra for giant cell arteritis
The FDA has granted a breakthrough therapy designation to Actemra for the treatment of giant cell arteritis, for which no therapies have been approved in more than 50 years, according to a Genentech press release.“The FDA breakthrough therapy designation for [giant cell arteritis] GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. “We are looking forward to working with the FDA in the hope of making (Read more...)