Richard Mark Kirkner
August 19, 2021
With worldwide supplies of tocilizumab dwindling as the COVID-19 pandemic rages on, a shortage of the agent will persist "for at least the next several weeks," according to Genentech, the Roche unit that manufactures tocilizumab under the trade name Actemra IV.
The World Health Organization and Unitaid have called on Genentech to guarantee equitable distribution of the biologic agent globally and to ease up on technology transfer restrictions to make the treatment more accessible.
At this point, supplies of tocilizumab for subcutaneous use to treat rheumatoid arthritis and its other approved indications for inflammatory conditions aren't as dire, but Genentech is watching them as well, the company says.
In June, the US Food and Drug Administration issued an emergency use authorization for intravenous tocilizumab for hospitalized COVID-19 patients. Since then, it has been included in the WHO Therapeutics and COVID-19 living guideline. And on the same day Genentech and Roche reported the tocilizumab shortage, the European Medicines Agency posted a statement that it had started evaluating RoActemra, the European brand name for tocilizumab, for hospitalized COVID-19 patients.
The FDA authorization has caused an unprecedented run on supplies for the biologic agent, which is FDA-approved to treat RA, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.
In the United States, stocks of the 200- and 400-mg units were unavailable, according to an FDA update this week on its website accessdata.FDA.gov, and the 80-mg/4 mL unit is available by drop ship only. Supplies of 80-mg units were expected to be depleted by the end of this week, Genentech said in a press release.
The company expects to resupply stocks by the end of August. "However," the Genentech statement added, "if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead."
For patients with RA or other approved indications taking the subcutaneous formulation — pens and prefilled syringes — supplies continue to be available, but, the company added, "the supply situation continues to evolve." The subcutaneous formulations aren't authorized for use in COVID-19 patients. However, the American Society of Health-System Pharmacists' website lists the 162 mg/0.9 mL prefilled syringe as one of the products affected by the shortage.
In a separate statement, Roche said that demand for tocilizumab increased 300% in developing countries over pre-pandemic orders, and that USo demand spiked more than 400% in the first two weeks of August.
Roche laid out four reasons for the shortage: global manufacturing capacity limits; raw material shortages; the overall complex process of manufacturing biologic agents; and "the dynamically evolving nature of the pandemic."
The Roche statement noted the company ramped up manufacturing of tocilizumab more than 100% over pre-pandemic capacity.
With regard to issues WHO and Unitaid raised in their statement, Roche stated that about 60% of its COVID-19 supplies have gone to developing countries, and that Roche and partner Chugai — both of whom hold tocilizumab-related patents — won't assert any patents over its use for COVID-19 in low- and middle-income countries (LMICs) during the pandemic.
"Roche is in the midst of discussions with WHO and we are committed to support access in LMICs as much as we can," a Roche spokesperson told Medscape Medical News.
Blair Solow, MD, chair of the American College of Rheumatology's government affairs committee, said the organization supports the equitable distribution of tocilizumab. "We will work to ensure that our patients continue to have access to the medications they need," she said. "We will continue to engage with the FDA and others to address shortages and ensure patient access to critical therapies."
The ACR said that any healthcare professionals having difficulty getting tocilizumab IV or any other COVID-19-related issues can contact the organization at [email protected].