Amid Actemra shortage, WHO asks Roche to ensure equitable access

Roche's arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and the World Health Organisation (WHO) wants the company to ensure that supplies don't just go to wealthy countries.

Earlier this week Roche's Genentech unit said it was facing unprecedented demand for Actemra (tocilizumab) – known as RoActemra in some markets – caused by the highly-transmissible spread of the delta variant of SARS-CoV-2. The situation would lead to scarcity for at least "several weeks," according to the company.

Today, the WHO and global health agency Unitaid called on the company to "ensure equitable allocation of current stocks of this medicine for all countries, including low- and middle-income countries."

They have also asked Roche to speed up its efforts to license out the technology needed to make the IL-6 inhibitor to other manufacturers, so that production capacity can be ramped up as quickly as possible.

Roche said on Monday that latest wave of infections had boosted Actemra order levels well over 400% of pre-COVID levels in the previous two weeks, and were continuing to rise.

Revenues from the drug have rocketed ever since the FDA granted emergency use authorisation for intravenously administered Actemra as a treatment for hospitalised patients with severe COVID-19 in June, but were already on the rise from compassionate use of the drug. Sales in the first half of this year were up 17% to approach $1.8 billion.

The demand have been driven by data from four trials involving more than 5,500 patients that – taken together – indicate that treatment with Actemra "may decrease the risk of dying" in qualifying COVID-19 patients, according to the FDA.

The EUA marked a turnaround in the fortunes of Actemra after initial studies reported in the early months of the pandemic yielded disappointing results.

Roche said this week it has already sold out of the drug in the US in 200mg and 400mg formulations, while 80mg versions would likely run out by the end of this week. New stock should arrive by the end of the month.

It does have supplies of the subcutaneous version of the drug, but that has not been authorised for use in treating COVID-19.

WHO and Unitaid said in a statement that they are working with Roche to set up channels for distribution of Actemra in places where it is not yet in use, and have also issued a call to identify potential manufacturers of the drug that could help swell global supplies.

The organisations added that they "remain committed to ensuring equitable access to medicines for treating patients with severe COVID-19 as a vital element of the effort to fight the pandemic everywhere and save lives."