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The monoclonal antibody had been given an emergency use authorization to treat COVID-19, but the recent spike in cases is driving a shortage in supply.
The spike in COVID-19 cases has led to a global shortage of Actemra (tocilizumab) supply for at least the next several weeks, according to officials from Genentech. The new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV, well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase.
In June 2021, the FDA issued an emergency use authorization (EUA) for Actemra for the treatment of hospitalized adults and pediatric patients older than 2 years who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In COVID-19, the immune system can become hyperactive, which may result in worsening of disease.
The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients, according to Genentech. The results of these studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
Company officials said that despite ramping up manufacturing ahead of the EUA, both Actemra IV 200 mg and 400 mg are out of stock as of August 16, 2021. There is limited supply of 80 mg, but they expect this be out of stock by the end of the week.
Although company officials expect the next scheduled stock to arrive by the end of August, they anticipate additional periods of shortages in the weeks and months to come if the pandemic continues at its current pace.
Actemra is currently FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis. The subcutaneous formulations (ACTPen and pre-filled syringe), which are not part of the EUA approval, continue to be available for patients prescribed the therapy for FDA-approved indications, though supply continues to evolve.
Genentech’s parent company Roche warned that global shortages are expected as well, due to global manufacturing capacity limits, raw material supply constraints, the complex, labor-intensive process of manufacturing biologics and the dynamically evolving nature of the pandemic.
The company indicated it is working with distributors and shipping carriers to find logistics solutions.