FDA Authorises Baricitinib, Remdesivir Combo for Hospitalised Patients With COVID-19
The US Food and Drug Administration issued an emergency use authorisation (EUA) for baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalised adults and paediatric patients aged 2 years and older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
In a clinical trial of hospitalised patients with COVID-19, baricitinib, in combination with remdesivir was shown to reduce time to recovery within 29 days after initiating treatment compared with patients who received remdesivir alone.
The safety and effectiveness of this investigational combination therapy for use in the treatment of COVID-19 continues to be evaluated.
Baricitinib is not authorised or approved as a stand-alone treatment for COVID-19.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalised patients, and FDA’s first authorisation of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.”
The data supporting this EUA are based on a randomised, double-blind, placebo-controlled clinical trial (ACTT-2). The trial followed patients for 29 days and included 1,033 patients with moderate or severe COVID-19. Of the patients, 515 received baricitinib plus remdesivir, and 518 patients received placebo plus remdesivir. Recovery was defined as either being discharged from the hospital or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 7 days for baricitinib plus remdesivir and 8 days for placebo plus remdesivir. The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group. The odds of clinical improvement at day 15 was also higher in the baricitinib plus remdesivir group.
Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results, and allergic reactions.
SOURCE: US Food and Drug Administration