Giant cell arteritis treatment expedited
The US Food and Drug Administration (FDA) is expediting its review of a new potential treatment for giant cell arteritis, a rare inflammatory disease that can cause permanent vision loss, Roche has announced.
The FDA and the European Medicines Agency have already approved tocilizumab (Actemra/RoActemra, Roche, Basel, Switzerland) for rheumatoid arthritis. Roche is seeking to add giant cell arteritis as an indication.
Under breakthrough status, the FDA will provide intensive guidance on efficient drug development, rolling reviews of aspects of an application and other support aimed at smoothing the path toward approval.
The breakthrough designation follows on from Roche’s June announcement of positive results in GiACTA, a phase III clinical trial in 251 patients at 76 sites in 14 countries including Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and the UK.
Although researchers have not released any details of their results, in a June press release Roche reported that tocilizumab, initially combined with a 6-month glucocorticoid regimen, more effectively sustained remission through 1 year compared with a 6 or 12 month steroid-only regimen in people with newly diagnosed and relapsing giant cell arteritis.
They identified “no new safety signals” in the study, and adverse events were similar to those seen in previous Actemra/RoActemra clinical studies.
The most common adverse events reported for tocilizumab include upper respiratory tract infections, nasopharyngitis, headache, hypertension, and abnormal liver function tests. The most serious adverse events are serious infections, complications of diverticulitis, and hypersensitivity reactions.
"The results of Genentech's GiACTA trial are encouraging for giant cell arteritis patients and the physicians who treat them," said Philip R Rizzuto, clinical associate professor of ophthalmic surgery at Brown University, Warren Alpert Medical School, in a Roche statement. "Long-term, high-dose steroid use can be problematic for many people. Having an alternative treatment would be welcome news."
If approved, tocilizumab would be the first new therapy available for giant cell arteritis in more than 50 years, according to Roche.