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Federal regulators have given the makers of Actemra approval to market the medication as a treatment for juvenile arthritis, despite growing concerns that side effects of Actemra may increase the risk of heart problems, infections and other risks typically associated with immunosuppressants.
Actemra SC has been approved by the FDA for treatment of active systemic juvenile ideopathic arthritis (JIA) among children two years of age or older. The approval is for a subcutaneous form of the drug, according to a press release issued by Genentech on September 13.
Genentech originally introduced Actemra (tocilizumab) in 2010, as a second-line medication primarily prescribed to treat severe cases of rheumatoid arthritis that may not have responded to other drugs. However, in May 2017, the drug maker obtained expanded approval of Actemra injections for giant cell arthritis.
Over the past decade, Actemra has become a blockbuster treatment, generating over $1.6 billion in annual sales, since it was widely thought by many doctors that it does not carry some of the same health risks associated with competing rheumatoid arthritis drugs, such as Humira, Remicade and Enbrel.
In recent months, concerns have emerged about potential Actemra health problems, after an 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 July, the findings of phase III clinical trials for the use of Actemra for giant cell arthritis showed that it had benefits for patients, but also revealed that 15% suffered adverse side effects.
Adding to the Actemra problems for Roche and it’s Genentech subsidiary, another study published in July in the medical journal Rheumatology found that individuals with a specific type of rheumatoid arthritis (RA), known as anti-citrullinated protein antibody (ACPA) negative, face a higher risk of infections than those with ACPA-positive rheumatoid arthritis.
Genentech indicated that a clinical study showed that Actemra SC had a similar safety profile of the intravenous version of the drug, however, more Actemra SC patients suffered injection site reactions. While the reactions were non-serious and no required withdrawal from the treatment, the problems affected 41% of patients involved in the clinical trials, who were between the ages of 1 and 17.
However, critics of the drug are more concerned about more serious side effects that do not appear on the drug’s 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 potential Actemra lawsuits, indicating that evidence suggests that Roche knew 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.