Attorneys Investigating Actemra Complaints and its Approval Process

Santa Clara, CAOn the heels of a STAT investigation that linked the rheumatoid arthritis drug Actemra to a number of deaths and many serious complications not listed on its label, attorneys are investigating potential lawsuits against Roche-Genentech, the manufacturer.

From the time of Actemra’s approval in 2010 until the STAT investigation published in June, 2017, the FDA had received more than 13,500 adverse event reports associated with the Rheumatoid Arthritis (RA) drug, including interstitial lung disease, pancreatitis, heart attack, heart failure, stroke and death. Altogether the STAT report reviewed more than 500,000 FDA adverse event reports related to various RA medications, but 487,000 of those reports were related to medications whose labels warned of some of the risks involved.

Not only does Actemra's labeling fail to warn; the STAT review "found clear evidence" that the potential for many of these complications, such as heart attack or stroke, "were as high or higher for Actemra patients than for patients taking some competing drugs”.

Even before Actemra’s approval, FDA reviewers were concerned about clinical data indicating that Actemra could increase blood lipid levels, potentially resulting in an elevated risk of heart attacks and other cardiovascular events. Regardless, Actemra was cleared on the condition that Roche-Genentech conduct long-term studies of its potential side effects.  So, why was Actemra brought to market without long-term studies?

The FDA has ways and means to speed up developers’ applications for new drugs, such as
fast track, breakthrough therapy’ and ‘priority review.’ As well, the agency can introduce an investigational drug to patients through its ‘expanded access’ mechanism and can allow access to a drug that is not fully approved through its ‘accelerated approval’ pathway.”

Actemra was approved by the fast track, 501(k) process based on data from the Phase III clinical trials of similar drugs SUMMACTA and BREVACTA. Roche only submitted to the FDA Actemra short-term studies—side effects listed in those studies did not include heart failure, stroke, or other serious side effects. Given this information, Actemra was considered a “breakthrough therapy” medication since it wasn’t reported to have the dangerous adverse effects that were associated with other RA drugs made by its competitors.

The FDA approval letter in January 2010 to Roche-Genentech stated that:
“Section 505(0)(3)(E)(ii} of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section. This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Section 506B of the FDCA, as well as 21 CFR 601.70, requires you to report annually on the status of any postmarketing commitments or required studies or clinical trials.”

Unfortunately for many of the 760,000 patients prescribed Actemra, it hasn’t proven itself to be the ‘breakthrough drug”. But fortunately for Roche Genentech, in 2016 Actemra brought in $1.7 billion in revenue.

If you have experienced any of Actemra’s unlabeled side effects detailed by STAT, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and more.