FDA gives Roche's Actemra emergency okay for severe COVID

Roche has been granted emergency approval by the FDA for its arthritis drug Actemra as a treatment for patients aged two or over who are hospitalised with severe COVOD-19 symptoms.

The green light for the IL-6 inhibitor comes as vaccines are reducing death rates in the US and other affluent parts of the world, although hospitalisation in the US are still running at more than 2,200 a week according to the latest figures from the Centres of Disease Control and Prevention (CDC).

Roche's drug has been given an emergency use authorisation (EUA) to treat patients with COVID-19 who are on systemic corticosteroids, and who need supplemental oxygen or are on a ventilator – in other worlds those at the highest risk of death.

The EUA marks a turnaround in the fortunes of Actemra – sold as RoActemra in some markets – after initial studies reported in the early months of the pandemic yielded disappointing results.

Coupled with similar trial failures for Sanofi's IL-6 drug Kevzara (sarilumab), that led to speculation that inhibiting IL-6 wasn't a valid approach to treat severe COVID-19. Later studies for both drugs were however more encouraging.

The EUA draws on 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 COVID-19 patients who fulfil the criteria for treatment under the EUA, according to the FDA.

Actemra was already being used in patients with COVID-19 in the US under compassionate use regulations, allowing Roche to record a spike in sales of the drug, which climbed 30% to around $688 million in the first quarter of this year.

The other drugs that can be used for hospitalised patients on steroids and needing respiratory support are Gilead Sciences' antiviral Veklury (remdesivir), given either alone or with Eli Lilly's JAK inhibitor Olumiant (baricitinib). So far Kevzara hasn't been given a green light in the US, although it is being used to treat severe COVID-19 in some countries including the UK.

Antibody therapies from GlaxoSmithKline, Regeneron and Lilly have also been granted EUAs but are used to treat mild-to-moderate COVID-19 patients at risk of going on to develop severe disease that requires hospitalisation.

"Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalisation, providing additional therapies for those who do become hospitalised is an important step in combating this pandemic," said Patrizia Cavazzoni, director of the FDA's Centre for Drug Evaluation and Research (CDER).