Roche has issued a statement regarding future shortages of their Actemra/RoActemra (tocilizumab) drug that has been widely used to treat hospitalized patients with severe or critical COVID-19 around the world. The demand for this medicine has increased to unprecedented levels globally beyond their manufacturing and supply capacity.
Actemra/RoActemra has been granted a U.S. FDA Emergency Use Authorization for hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Additionally, tocilizumab has also now been included in the WHO Therapeutics and COVID-19 living guideline, based on the body of evidence that has been generated throughout the last 18 months. Roche teams have been working around the clock to make Actemra/RoActemra available as quickly and widely as possible since the beginning of the pandemic.
In 2020, ahead of data on Actemra/RoActemra in COVID-19 becoming available, we ramped up our own manufacturing network and contracted with all available large-scale manufacturers around the world to transfer our technologies and maximize production. We have also worked with distributors globally to flexibly manage product supply to enable both Roche and our partners to quickly fulfil requests to meet patient needs.
As a result, in 2021 Roche has supplied Actemra/RoActemra at levels that have increased by more than 100% compared to before the pandemic. So far, approximately 60% of our estimated COVID-19 supply has gone to developing countries, following the urgent need and representing 300% growth compared to the pre-pandemic supply to these countries.
Despite all these efforts, the unfortunate reality is that due to the unprecedented surge in worldwide demand - with US demand spiking to well-beyond 400% of pre-COVID levels over the last two weeks alone - Roche will experience shortages of Actemra/RoActemra globally over the weeks and months ahead.
This is 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. We have been doing everything possible to minimize the impact of supply constraints and have a controlled distribution strategy in place for people with conditions for which Actemra/RoActemra is approved.
Roche will continue to work closely with global health authorities and our partners to help these patients with COVID-19, as quickly as possible. Roche is also investigating other treatment approaches to help minimize the impact of COVID-19, including a direct acting antiviral, that may help prevent patients from progressing to severe illness and a monoclonal antibody combination. The antibody combination known as Ronapreve has been authorized for emergency use or temporary pandemic use in territories and regions, including in the European Union, United States, India, Switzerland and Canada, and has been approved in Japan.