Roche says Phase III trials for giant cell arteritis drug met primary endpoint
Cancer drugmaker Roche (SIX: ROG) said late stage trials for its drug to treat giant cell arteritis (GCA) met its primary endpoint.
The company said the Phase III study for Actemra/RoActemra (tocilizumab) initially combined with a six month steroid (glucocorticoid) regimen, showed more effective sustained remission through one year.
Sandra Horning, Chief Medical Officer said: “These results are encouraging for patients with this rare disease, for which there have been no new treatments in more than 50 years. Currently, long-term high-dose steroids are the mainstay treatment for GCA but they can cause their own serious adverse effects. If approved, Actemra/RoActemra will provide an important new alternative to long-term steroid use for people with GCA.”
GCA is a serious condition where arteries, commonly in the head but also the aorta and its branches, become inflamed. This inflammation can lead to persistent and severe headaches, scalp tenderness and jaw and arm pain. It is difficult to diagnose and if left untreated, GCA may lead to blindness, stroke or aortic aneurysms. Vision problems occur in about 30% of people with GCA, and about 15% experience permanent vision loss.
The occurrence of GCA has been estimated at over 200 per 100,000 persons in the US over the age of 50.5 An even higher frequency has been reported in northern Europe. GCA is two to three times more likely to affect women and is often difficult to diagnose due to the wide and variable spectrum of signs and symptoms. With no new treatments in more than 50 years, people with GCA are limited to high-dose steroid treatment that generally fails to cure GCA or induce long-term steroid-free remissions.
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