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 Results from the study showed that 56 percent of patients treated
with Actemra - known as RoActemra in European markets -achieved
steroid-free disease remission at one year, versus 14 percent with a
six-month steroid only taper regimen, Roche said in a statement.
Giant cell arteritis (GCA) is a chronic, potentially
life-threatening autoimmune condition caused by inflammation of
large and medium-sized arteries, most often in the head but also in
the aorta and its branches. It generally affects people over the age
of 50.
"Treatment to date for GCA has been limited to high-dose steroids to
rapidly control inflammation and prevent serious complications such
as vision loss," said Sandra Horning, Chief Medical Officer and Head
of Global Product Development.
However, steroid treatment often failed to control disease in the
long term and could be associated with severe side effects, she
said.
"If approved, Actemra could have the potential to fundamentally
change the way people with GCA are treated."
Actemra is Roche's fifth-best-selling medicine, with first-half 2016
sales rising 17 percent to 814 million Swiss francs as doctors
prescribed it for rheumatoid arthritis and juvenile idiopathic
arthritis.
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The U.S. Food and Drug Administration had granted breakthrough
status to Actemra's rheumatoid arthritis medication for giant cell
arteritis in October.
The study results will be submitted to regulatory authorities around
the world by end of 2016, Roche said.
(Reporting by Kirsti Knolle; Editing by Elaine Hardcastle)
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