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1 DNA Way paves way to FDA
SOUTH SAN FRANCISCO, Calif.—Targeted toward conducting clinical trials on drugs to cure rare diseases, global biotech Genentech, residing at 1 DNA Way, is poised to seek U.S. Food and Drug Administration (FDA) approval of Actemra for the remission of giant cell arteritis (GCA), the most common form of vasculitis in patients age 50 and older. If results of a recent study prove to have merit, Genentech could soon be on its way to become the first company to get FDA approval for a drug to treat GCA.
The Lancet published the investigator-sponsored trial study online March 4, portraying Actemra as an effective treatment for the induction and maintenance of remission in patients with GCA, a disease characterized by inflammation of the blood vessels in the scalp, neck and arms, as well as permanent visual impairment, which may occur in as many as 20 percent of GCA patients.
“There is currently no FDA-approved treatment for GCA,” William Reiss, associate group medical science director for Genentech, tells DDNews. “Glucocorticoids are the current standard of care.”
GCA “affects approximately 228,000 adults in the U.S.,” he notes. “Women are three to 3.5 times more likely to be affected than men, with the median age of onset approximately 75 years.”
The cause of the disease is unknown and the diagnosis process is complicated by the fact that no single test is definitive, Reiss says. People suffering from GCA may have higher risks of heart attacks, strokes and peripheral artery disease, and an increased risk of death from the complications of aortic aneurysms.
Genentech is “currently conducting a Phase 3 trial (GiACTA) to investigate the safety and efficacy of Actemra (tocilizumab) in the treatment of patients with GCA,” Reiss said. “Once the GiACTA trial has been completed, we will evaluate the data and assess our next steps.”
In 2010, the FDA approved Actemra, the first interleukin-6 (IL-6) receptor antagonist for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs, such as methotrexate (MTX) that did not provide enough relief.
The FDA approved Actemra in 2011 to treat patients with active systemic juvenile idiopathic arthritis two years of age and older. In 2013, Genentech won FDA approval of a subcutaneous formulation for use in adult patients with moderately to severely active RA.
In The Lancet article, the Genentech study authors state that the current treatment for GCA is “glucocorticoids, the gold-standard, which prevents severe vascular complications but is associated with substantial morbidity and mortality. Actemra, a humanized monoclonal antibody against the interleukin-6 receptor, has been associated with rapid induction and maintenance of remission in patients with giant cell arteritis. We therefore aimed to study the efficacy and safety of Actemra in the first randomized clinical trial in patients with newly diagnosed or recurrent giant cell arteritis.”
Relapse-free survival “was achieved in 17 (85 percent) patients in the Actemra group and two (20 percent) in the placebo group by week 52,” the study states. “The mean survival-time difference to stop glucocorticoids was 12 weeks in favor of Actemra (95 percent). Seven (35 percent) patients in the Actemra group and five (50 percent) in the placebo group had serious adverse events.
“Our findings show, for the first time in a trial setting, the efficacy of Actemra in the induction and maintenance of remission in patients with giant cell arteritis,” the article concluded.