Actemra Approval Expanded Amid Increasing Safety Concerns

Despite growing concerns the side effects of Actemra, and questions about whether the rheumatoid arthritis drug warnings are adequate, federal regulators have approved the expanded use of the medication to treat severe or life-threatening cytokine release syndrome (CRS), caused by CAR-T therapy. 

Roche issued a press release on August 30, announcing the FDA’s decision to expand approval for Actemra and RoActemra as a treatment for cell-induced cytokine release syndrome caused by CAR-T, which is a cell immunotherapy treatment used to treat some types of cancers.

Cytokine release syndrome is an overactive immune response that ranges from flu-like symptoms to life threatening complications, such as heart problems, acute respiratory distress or multiple organ failure.

Actemra (tocilizumab) was introduced in 2010, as a second-line treatment for rheumatoid arthritis, in severe cases where individuals have not responded to other drugs. In May 2017, the FDA approved expanded use to treat giant cell arteritis, and the medication has grown to generate over $1.6 billion in annual sales.

This latest approval means that the drug can be marketed by Roche to even more patients, who would also be exposed to the potential side effects, including those that some say are not adequately disclosed on the label.

Unlike other competing rheumatoid arthritis drugs, Actemra warnings do not include information about certain health risks linked to competing treatments, such as Humira, Remicade and Enbrel. Therefore, many doctors and consumers are under the impression that Actemra is safer. However, recent reports suggest that users may face the same, or higher risks.

A recent independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010. As a result, some are calling for Actemra warnings to be added, which may cut into sales.

A number of product liability lawyers are now reviewing the potential for Actemra lawsuits for individuals who have experienced problems, suggesting that Roche new or should have known that the drug carried similar risks to other rheumatoid arthritis drugs, but withheld information from the label to create a false impression that their drug was safer.