Roche nabs FDA emergency nod for Actemra in severe COVID-19 despite mixed trial results

Roche’s Actemra may have turned up mixed results in COVID-19 clinical trials, but the FDA thinks the rheumatoid arthritis drug has shown enough benefit in some severe patients to deserve an emergency use authorization.

The FDA on Thursday authorized Actemra to be used alongside corticosteroids for hospitalized patients who require some form of oxygen support.

Doctors have already been treating severe patients with Actemra before the EUA. Thanks to additional use in COVID-19 last year, the drug enjoyed a 32% sales jump at constant exchange rate to CHF 2.86 billion ($3.12 billion).

Actemra joins Eli Lilly’s fellow arthritis med Olumiant on the anti-inflammatory side of the FDA treatment list for COVID patients. Other drugs such as Gilead Sciences’ Veklury directly target the coronavirus.

Last year, Chinese doctors first proposed the potential application of Actemra in COVID, suggesting the med's anti-IL-6 effects could tamp down inflammation. Officials quickly included the medicine in the country's treatment guidelines after doctors noted benefits in some patients with severe pneumonia.

But carefully designed clinical trials that aimed to corroborate the anti-IL-6 theory have since returned mixed results on various outcome markers in different patient populations.

RELATED: Roche's Actemra helps keep coronavirus patients off ventilators despite earlier trial flop

For the EUA, the FDA evaluated data from four clinical trials. The Roche-sponsored COVACTA trial was the first to report data. In that study, Actemra failed to outperform placebo at helping severe patients improve clinical status on a seven-point scale through 28 days.

Then, the Empacta trial showed the use of Actemra alongside standard of care pared down the risk of hospitalized patients progressing to mechanical ventilation or death by 44% after 28 days. To further complicate the situation, the REMDACTA study showed adding Actemra to Veklury didn’t shorten the time severe patients had to stay in the hospital.

The FDA’s EUA decision appears to lean more heavily on results from the large-scale RECOVERY trial by the U.K.’s National Institute for Health Research, which first confirmed the lifesaving benefit of the low-cost steroid dexamethasone in controlling inflammatory lung damage from COVID

RELATED: Roche's arthritis drug Actemra scores FDA nod in rare autoimmune disease after partial clinical win

In RECOVERY, investigators tested Actemra plus usual care versus usual care alone in more than 4,000 patients. About 82% of patients received a steroid as part of usual care. The trial showed that the addition of Actemra could lower the chance of progressing to invasive ventilation or death to 33%—from 38%—by Day 28. For every 25 patients treated with Actemra, one additional life would be saved, the team said.

Even with the new EUA, Genentech CEO Alexander Hardy said the company would work with partners to enable access to the drug for all patients.

Roche and Genentech are currently following some patients from the three company-sponsored trials for long-term outcome data, Jamie Freedman, M.D., Ph.D., Genentech’s head of medical affairs, said via email. 

Editor's note: This story has been updated to clarify a statement by Genentech CEO Alexander Hardy about Actemra supply.