The manufacturers of Actemra are exploring yet another indication for the rheumatoid arthritis (RA) treatment, despite a recent analysis that linked the medication to thousands of adverse events, including heart attacks, strokes, pancreatitis, and death.
Actemra belongs to a class of novel RA drugs that block the action of interleukin-6 (IL-6), which is believed to play a role in the disease. Actemra was first approved by the U.S. Food & Drug Administration (FDA) in 2010, and is now indicated for use in:
Before the FDA approved Actemra, agency reviewers did express concerns about clinical data that suggested the medication could increase blood lipid levels, potentially resulting in an elevated risk of heart attacks and other cardiovascular events. As a result, the FDA cleared Actemra on the condition its manufacturers conduct long-term studies of its potential side effects.
In June, STAT reported that its analysis of FDA adverse event reports involving various RA drugs had uncovered more than 13,000 incidents associated with Actemra, including heart attack, interstitial lung disease, stroke, and pancreatitis. The reports also implicated Actemra in more than 1,100 deaths.
While the labels for many other RA treatments include warnings for some of these side effects, Actemra’s does not.
Despite the concerns raised by STAT, Genentech and Roche AG continue to pursue new indications for Actemra. In a press release issued this week, Genentech announced it had completed enrollment for a phase 3 clinical trial to investigate the use of Actemra in patients with systemic sclerosis.
Systemic sclerosis is an autoimmune disorder characterized by changes in the texture and appearance of the skin due to increased collagen production. The disease can also effect the blood vessels, muscles, heart, lungs, kidneys, and digestive system.
The FDA granted Actemra Breakthrough Therapy Designation for systemic sclerosis in June 2015, which allows for expedited development and review of medications to treat serious or life-threatening conditions.
“Having reached our first milestone of completing enrollment, we continue to push forward with the determination that we can potentially deliver a therapeutic option to a patient population that has serious unmet need,” Jeffrey Siegel, MD, global head of rheumatology and rare diseases at Genentech, said in the company’s release. “We hope the phase 3 trial results will show that treatment with Actemra not only shows improvement in skin thickening over time, which is crucial for these patients, but also the preservation of lung function.”